Weekly Recall Recap

2026-09-07 to 2026-09-13

148
Recalls
834,709
Units
1
Injuries
0
Deaths

Sources: FDA_DRUG, FDA_FOOD, CPSC, NHTSA, FDA_DEVICE

Other Recalls

FDA Drug2026-09-13
FDA Recall: Centric Compounding: Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL mu
Centric Compounding

Elevated Endotoxin level

FDA Food2026-09-11
FDA Recall: Whole Foods Market: Cheese
Whole Foods Market

Undeclared Egg

CPSC2026-09-103,992 units
Dual Fuel Ranges Recalled Due to Risk of Serious Injury or Death from Fire or Explosion Hazards; Manufactured by AGA Rangemaster
AGA Rangemaster Limited, of United Kingdom

Dual Fuel Ranges with a missing cap from the gas test port can cause a gas leak,​ posing a risk of serious injury or death from fire or explosion hazards.

CPSC2026-09-10245,124 units
ZMC Group Expands Recall of Light-Up Children’s Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
ZMC Group Inc., of Los Angeles, California

The recalled light-up toys violate the mandatory safety standard for children’s toys because the toys contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.

NHTSA2026-09-10195 units
Rearview Camera Image May Not Display
Forest River Bus, LLC

A rearview image that does not display properly reduces the driver's view behind the vehicle, increasing the risk of a crash.

NHTSA2026-09-103,038 units
Roof Rack Crossbars May Detach
Chrysler (FCA US, LLC)

Detached roof rack crossbars can create a road hazard, increasing the risk of a crash.

NHTSA2026-09-1097,349 units
Roof Rack Crossbars May Detach
Chrysler (FCA US, LLC)

Detached roof rack crossbars can create a road hazard, increasing the risk of a crash.

NHTSA2026-09-1086 units
Loss of Power or Fire Risk from Incorrect BECM Software
Ford Motor Company

An inaccurate state-of-charge reading can lead to an unexpected loss of drive power, increasing the risk of crash. Additionally, a high voltage battery fire increases the risk of injury.

NHTSA2026-09-1083 units
Loss of Power or Fire Risk from Incorrect BECM Software
Ford Motor Company

An inaccurate state-of-charge reading can lead to an unexpected loss of drive power, increasing the risk of crash. Additionally, a high voltage battery fire increases the risk of injury.

NHTSA2026-09-1060 units
Exterior Stowed Griddle Can Cause Fire
Forest River, Inc.

A griddle stowed while the gas is still in use can increase the risk of a fire.

CPSC2026-09-10179,739 units
Cade California Electronic Recalls Finger Light Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
California Cade Electronic, LLC, of Hacienda Heights, California

The recalled finger lights violate the mandatory safety standard for toys because the toys contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.

CPSC2026-09-102 units
Ricky Joy Recalls More Than 2.3 Million Sour Crush Candy Bottles Due to Risk of Serious Injury or Death from Choking Hazard
International Trade Imports LLC (The Ricky Joy Company), dba Ricky Joy, of Cumming, Georgia

The rolling ball on the recalled candy bottles can detach, posing a risk of serious injury or death from choking hazard.

CPSC2026-09-1012,461 units
Sweet Cubby Recalls Children's Loungewear Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standard for Children's Sleepwear
Hong Kong Xuheyuan Trading Co., Ltd, dba Sweet Cubby, of China

The recalled children’s loungewear sets violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.

CPSC2026-09-102,295 units
Guang Zhou Recalls Wantefully Hair Dryer Brushes Due to Risk of Serious Injury or Death from Electrocution, Shock and Burn Hazards; Violate Federal Regulations
Guang Zhou Shi Wan Te Fu Ke Ji You Xian Gong Si, dba Wantefully, of China

The recalled hair dryer brushes are in violation of federal regulations for hair dryers as they lack an integrated immersion protection device, which presents a substantial product hazard to consumers and the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in. In addition, the recalled hair dryer brushes can overheat, posing a burn hazard.

CPSC2026-09-101,835 units
SQT Recalls Lontcs Busy Boards Due to Risk of Serious Injury from Lead Poisoning; Violate Federal Lead Paint Ban
Xianyouxianlichengshaungqiaotouqichemeirongdian (Xianyou County Licheng Shuangqiaotou Auto Beauty Shop), dba SQT LLC, of China

The toys’ zipper contains levels of lead that exceed the standard set in the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues.

CPSC2026-09-101,738 units
Junkins Recalls DHASUWT Hair Dryer Brushes Due to Risk of Serious Injury or Death from Electrocution, and Shock Hazards; Violate Federal Regulations; Smoking and Fire Hazards
Shenzhen Weihua Chenyu Technology Co., Ltd, dba Junkins, of China

The recalled hair dryer brushes lack an integrated immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in to an electrical source. The recalled hair dryer brushes also pose the risk of death or serious injury from smoking and fire hazards.

CPSC2026-09-1031,000 units
Prepared Hero Recalls Fire Spray Canisters Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Prepared Hero, of Sheridan, Wyoming

The recalled fire spray canister can deteriorate overtime, causing it to rupture and fail to operate during a fire, posing the risk of serious injury or death from fire and burn hazards.

CPSC2026-09-101,560 units
Triumph Motorcycles Recalls Closed Course Competition Motorcycles Due to Risk of Serious Injury or Death from Crash Hazard
Triumph Motorcycles America Ltd., of Atlanta, Georgia

The engine rocker arm on the recalled motorcycles can seize or stick and the exhaust valves can remain open or break, posing a risk of serious injury or death from a crash hazard.

CPSC2026-09-1040 units
Victgoal Recalls Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury; Violate Mandatory Standard for Bicycle Helmets
Dongguan Hongtu Sports Goods Co. Ltd., of China

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the retention system, positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.

CPSC2026-09-109,000 units
FJTJBSI Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Fujian Laobosi Cross-Border E-commerce Co., Ltd., dba FJTJBSI, of China

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.

NHTSA2026-09-102,404 units
Modulator Valve Corrosion May Cause Brake Pull
Daimler Trucks North America, LLC

Brakes that pull to one side may cause a sudden change in vehicle direction, increasing the risk of a crash.

FDA Food2026-09-10
FDA Recall: No Brand Name: Broccoli Sprouts
No Brand Name

Potential to be contaminated with Salmonella

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Drug2026-09-09
FDA Recall: Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intr
Chiesi USA, Inc.

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

FDA Drug2026-09-09
FDA Recall: Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Conta
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container,
Baxter Healthcare Corporation

CGMP Deviations

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLM
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3
Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

FDA Device2026-09-09
FDA Recall: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

FDA Device2026-09-09
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model
Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERI
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT,
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CUL
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Numbe
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Softwa
Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHE
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-S
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DY
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOT
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/C
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

FDA Device2026-09-09
FDA Recall: Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc

Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

FDA Device2026-09-09
FDA Recall: Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1
Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN L
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT,
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Food2026-09-09
FDA Recall: Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR
Prince Bakery Inc

Milk is not declared in the Contains statement.

FDA Food2026-09-09
FDA Recall: Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Fo
Ukrop's Homestyle Foods LLC

Foreign object: metal fragments

FDA Drug2026-09-09
FDA Recall: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 10
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Co
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL S
Baxter Healthcare Corporation

CGMP Deviations

FDA Food2026-09-09
FDA Recall: OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible p
Fayus Inc.

Undeclared milk.

FDA Drug2026-09-09
FDA Recall: Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Co
Baxter Healthcare Corporation

CGMP Deviations

FDA Food2026-09-09
FDA Recall: Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic container.
Ron's Home Style Foods, Inc.

Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella

FDA Food2026-09-09
FDA Recall: Organic Cheddar Type Seasoning, NET WT: 50 lbs. Product is packaged in bulk poly-lined paper bag. Sa
Savor Seasonings LLC

Product tested positive for undeclared milk allergen.

FDA Device2026-09-09
FDA Recall: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22
AVID Medical, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Drug2026-09-09
FDA Recall: Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonp
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5
Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULT
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

FDA Device2026-09-09
FDA Recall: Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

FDA Device2026-09-09
FDA Recall: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

FDA Device2026-09-09
FDA Recall: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quan
Diagnostica Stago, Inc.

A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DY
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model
Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

NHTSA2026-09-097 units
Passenger Air Bag May Deploy Improperly
Ford Motor Company

An air bag that does not deploy as intended increases the risk of injury in a crash.

NHTSA2026-09-092,711 units
Bracket May Tear Side Curtain Air Bag
Ford Motor Company

A torn air bag may fail to properly restrain an occupant during a crash, increasing the risk of injury.

NHTSA2026-09-091,945 units
Wireless Seat belt Reminder Malfunction
Ford Motor Company

A faulty seat belt status indicator may fail to alert occupants to an unfastened seat belt, increasing the risk of injury.

NHTSA2026-09-09223,472 units
Fuel Tank May Leak or Detach
Ford Motor Company

A detached tank can create a road hazard, increasing the risk of a crash. In addition, a fuel leak can cause an engine stall or increase the risk of a fire.

NHTSA2026-09-0937 units
Loss of Drive Power from Incorrect Rear Axle Tail Bearing
Ford Motor Company

Rear wheel lock-up can result in a loss of vehicle control. Driveshaft separation can result in a loss of drive power, or a vehicle rollaway if the vehicle is parked without the parking brake applied. Either of these situations can increase the risk of a crash or injury.

FDA Device2026-09-09
FDA Recall: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2
Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

FDA Device2026-09-09
FDA Recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model
Boston Scientific Corporation

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Drug2026-09-09
FDA Recall: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/m
Baxter Healthcare Corporation

CGMP Deviations

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHON
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ3
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Drug2026-09-09
FDA Recall: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5
Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXIL
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

NHTSA2026-09-0917 units
Loose Rear Suspension Stabilizer Rod
Ford Motor Company

A misaligned stabilizer rod can cause a loss of vehicle handling and control, which can increase the risk of a crash.

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Food2026-09-09
FDA Recall: Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in
WEIS MARKETS, INC.

Product has high patulin levels

FDA Food2026-09-09
FDA Recall: Bread Pudding with Vanilla Sauce NET WT 13.8 OZ (39g) UPC 7 22515 28044 8 Ukrop's Homestyle Foods, L
Ukrop's Homestyle Foods LLC

Foreign object: metal fragments

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Wonton Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Lo Mein Noodle, 16 oz, packaged in clear plastic bags
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Dumpling Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Drug2026-09-09
FDA Recall: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dos
Baxter Healthcare Corporation

CGMP Deviations

FDA Device2026-09-09
FDA Recall: 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPIN
AVID Medical, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

FDA Drug2026-09-09
FDA Recall: Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dos
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: C
Supernus Pharmaceuticals, Inc.

Failed dissolution specifications.

FDA Drug2026-09-09
FDA Recall: Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American
American Health Packaging

Labeling: Label Mix-up

FDA Drug2026-09-09
FDA Recall: traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva
Teva Pharmaceuticals USA, Inc

Presence of Foreign Tablets/Capsules

FDA Drug2026-09-09
FDA Recall: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5
Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

FDA Drug2026-09-09
FDA Recall: Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed o
Lexia LLC

CGMP Deviations: Potential contamination of raw material

FDA Drug2026-09-09
FDA Recall: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Ga
Baxter Healthcare Corporation

CGMP Deviations

FDA Drug2026-09-09
FDA Recall: Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Conta
Baxter Healthcare Corporation

CGMP Deviations

FDA Food2026-09-09
FDA Recall: Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g); INGREDIENTS: ENRICHED BLEACHED FLOUR,
Prince Bakery Inc

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

FDA Drug2026-09-09
FDA Recall: Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, Hemp
Lexia LLC

CGMP Deviations: Potential contamination of raw material

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Food2026-09-09
FDA Recall: Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT F
Prince Bakery Inc

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

FDA Drug2026-09-09
FDA Recall: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Co
Baxter Healthcare Corporation

CGMP Deviations

FDA Food2026-09-09
FDA Recall: Frankie's Organic Plant-Based Puffs Vegan Cheddar, NET WT. 4 oz. (113 g). Product is packaged into f
Marina Del Rey Foods inc.

Product tested positive for undeclared milk.

FDA Drug2026-09-09
FDA Recall: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5
Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

FDA Drug2026-09-09
FDA Recall: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx On
Bionpharma Inc.

Presence of Foreign Tablets/Capsules

FDA Drug2026-09-09
FDA Recall: 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three O
Sage Products, LLC

Cross Contamination with Other Products

FDA Drug2026-09-09
FDA Recall: Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceut
Mylan Pharmaceuticals Inc

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

FDA Drug2026-09-09
FDA Recall: Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-D
Baxter Healthcare Corporation

CGMP Deviations

FDA Food2026-09-09
FDA Recall: Item #DIPSAU0205RFS Salsa Autentica 5 lb. packaged in round plastic container.
Ron's Home Style Foods, Inc.

Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella

FDA Drug2026-09-09
FDA Recall: Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, R
Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

FDA Drug2026-09-09
FDA Recall: Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camari
Golden State Medical Supply Inc.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Food2026-09-09
FDA Recall: Wonton Specialist Inc. Wonton Noodle, 12 oz - packaged in foam tray overwrapped with clear plastic a
Wonton Specialists

Undeclared FD&C Red No. 40

FDA Device2026-09-09
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBO
Cardinal Health 200, LLC

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

FDA Device2026-09-09
FDA Recall: HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON E
Johnson & Johnson Surgical Vision, Inc.

Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.

FDA Drug2026-09-09
FDA Recall: Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx
Baxter Healthcare Corporation

CGMP Deviations

FDA Device2026-09-09
FDA Recall: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades P
Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

FDA Device2026-09-09
FDA Recall: Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT,
AVID Medical, Inc.

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

FDA Device2026-09-09
FDA Recall: Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ing
Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

FDA Device2026-09-09
FDA Recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for B
Fresenius Medical Care Renal Therapies Group, LLC

Complaints of blue-green discoloration in product

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYK
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT D
Medline Industries, LP

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA Device2026-09-09
FDA Recall: Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG,
Medline Industries, LP

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA Device2026-09-09
FDA Recall: Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Baxter Healthcare Corporation

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

FDA Drug2026-09-09
FDA Recall: MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, B
Baxter Healthcare Corporation

CGMP Deviations

FDA Device2026-09-08
FDA Recall: BMC: Luna G3 APAP (Model LG3600)
BMC

The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect

FDA Food2026-09-08
FDA Recall: FI: Supplements
FI

Potential to be contaminated with Salmonella

NHTSA2026-09-0814,014 units
Instrument Cluster May Fail/FMVSS 122, 123
Bombardier Recreational Products, Inc.

An inoperative instrument cluster will fail to display critical safety information, such as vehicle speed and warning lights, increasing the risk of a crash.

NHTSA2026-09-08505 units
Printed Circuit Board May Overheat
Kibbi, LLC

An overheated printed circuit board increases the risk of a fire.

FDA Drug2026-09-08
FDA Recall: BMC: Luna G3 APAP (Model LG3600)
BMC

The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect

FDA Food2026-09-08
FDA Recall: Created Fresh!: Cranberry Chicken Salad Wedge Sandwich
Created Fresh!

Improperly declared egg allergen

FDA Device2026-09-08
FDA Recall: BMC: Luna G3 APAP (Model LG3600)
BMC

The firmware version, G3-2.00.76 installed on the Luna G3 APAP (Model LG3600) devices contained a firmware defect