Weekly Recall Recap

FDA Recall: Philips OMNI III TEE Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

FDA Recall: Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tofu, and Hijiki Seaweed. SKU #097

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article n

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A,

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

FDA Recall: Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Erbe USA Inc

Probes may rupture/burst during activation

FDA Recall: I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article n

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions a

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

FDA Recall: Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). Frozen. Shelf life: 365 days (frozen) fro

Sevillo Fine Foods, Inc

Product may contain foreign material (metal fragments).

FDA Recall: Item 6430153 Ajinomoto Vegetable Gyoza Dumplings. Net wt. 24.7oz. per bag. Retail box UPC: 071757010

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Basil Pesto & Mozzarella Pizza NET WT. 13.90OZ (394g) UPC 8 57919 00785 5 Distributed by: Grocery De

Bakkavor

Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.

FDA Recall: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi US

Chiesi USA, Inc.

Lack of Assurance of Sterility

FDA Recall: Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:***Mustard

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed

Lidl US TRADING

Label does not specify type of tree nut contained in the product.

FDA Recall: Tops GOLD Khatta Meetha Pickle NET QTY.: 33.51oz PRODUCT OF INDIA UPC: 8904288611427 INGREDIENTS:***

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: Claviculaplate with Angular Stability, with the below descriptions and associated article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutti

FDA Recall: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

FDA Recall: Philips C9-4 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Slow Roasted Diced Tomatoes (SKU 821, UPC 00823338008216). Frozen. Shelf life: 365 days (frozen) fro

Sevillo Fine Foods, Inc

Product may contain foreign material (metal fragments).

FDA Recall: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL

Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

FDA Recall: Doraditas de Azucar UPC 5901234123457

Distribuidora de Alimentos Sendero LLC

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

FDA Recall: Philips Mini Multi TEE Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Straumann USA LLC

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

FDA Recall: Philips 3D6-2 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Nu

FDA Recall: Philips X3-1 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Waldemar Link GmbH & Co. KG (Mfg Site)

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

FDA Recall: Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. A

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog

FDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar

FDA Recall: Philips X7-2 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance

AMO Puerto Rico Manufacturing, Inc.

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

FDA Recall: I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding art

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Straumann USA LLC

FDA Recall: Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

FDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod

Koven Technology, Inc.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

FDA Recall: King Harvest brand Balsamic Hummus. Product is packed in 10oz plastic tubs with a clear film seal an

Foreign material (aluminum pieces).

FDA Recall: I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descr

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Pepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Oma

American Laboratories, LLC

Potential Salmonella contamination.

FDA Recall: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Hume

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Erbe USA Inc

Probes may rupture/burst during activation

FDA Recall: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Mode

FDA Recall: Philips L12-5 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2"

Medline Industries, LP

Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

FDA Recall: King Harvest brand Jalapeno Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film

Foreign material (aluminum pieces).

FDA Recall: Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and

Albertsons Companies LLC

Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.

FDA Recall: Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:***Mustard

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article num

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. Retail bag UPC 00521482. Produ

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain white rice and crispy vegetabl

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavore

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: SiluetaYa Mexican Tejocote Roots Supplement Pieces; 7g/bottle; Dietary Supplement, UPC#: 7500464462

Siluetaya, LLC

Product contains yellow oleander

FDA Recall: Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package U

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:***M

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: 14" Margarita Thin Crust Pizza; 8 units per case. Keep Frozen UPC code: 1713940060

Rose and Shore, Inc.

potential foreign object (metal pieces) in ingredient (Tomatoes)

FDA Recall: Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct. Retail bag UPC: None. Produc

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for us

Beckman Coulter, Inc.

Due to the likely presence of contamination in well(s).

FDA Recall: Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENT

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: King Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film

Foreign material (aluminum pieces).

FDA Recall: King Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and

Foreign material (aluminum pieces).

FDA Recall: Philips OMNI II TEE Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Nuts.com, Espresso Malted Milk Balls, 1 lb. sealed pouch & 20 lb. clear poly bag in Nuts.com cardboa

Nuts.com Inc.

Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy.

FDA Recall: Philips S5-2 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO.

Erbe USA Inc

Probes may rupture/burst during activation

FDA Recall: FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below description

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Tops GOLD Lime Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611397 INGREDIENTS:***Mustard O

Potential adulteration with erucic acid from mustard oil ingredient.

FDA Recall: Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

NRS Enterprises, Inc. dba Sunflour Bakery

Undeclared sesame seed ingredient in hamburger buns.

FDA Recall: King Harvest brand Black Olive Hummus. Product is packed in 10oz plastic tubs with a clear film seal

Foreign material (aluminum pieces).

FDA Recall: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-N

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

FDA Recall: Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN

South Florida Food, LLC

Undeclared Soy.

FDA Recall: Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of long grain rice assorted veget

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MU

Savannah Bee Company Inc.

Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label.

FDA Recall: Roasted Tomato Parmesan Focaccia Bread sold under the brand names of FREDERIK'S by meijer SLOW-ROAST

Bakkavor

Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.

FDA Recall: King Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a

Foreign material (aluminum pieces).

FDA Recall: Pepsin 1:3000 Powder, 50 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha

American Laboratories, LLC

Potential Salmonella contamination.

FDA Recall: Chilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item co

Western Mixers Produce & Nuts, Inc.

Foreign object (glass) found inside sealed container of finished product.

FDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C

FDA Recall: Gorditas de Azucar UPC 860010238134

Distribuidora de Alimentos Sendero LLC

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

FDA Recall: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL

Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

FDA Recall: Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, eda

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

FDA Recall: Chilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608

Western Mixers Produce & Nuts, Inc.

Foreign object (glass) found inside sealed container of finished product.

FDA Recall: Bulk packaged Colustrum Powder. packaged with generic product label.

Herbal Creations USA

Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.

FDA Recall: Pepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Oma

American Laboratories, LLC

Potential Salmonella contamination.

FDA Recall: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL

Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

FDA Recall: Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods P

MACLEODS PHARMA USA, INC

Subpotent Drug

FDA Recall: Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg

Amerisource Health Services LLC

Failed tablet specifications.

FDA Recall: Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dib

Radnostix

Failed Tablet/Capsule Specifications

FDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Orthalign, Inc

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

FDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Orthalign, Inc

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

FDA Recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA Recall: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Artic

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

FDA Recall: Philips S4-1 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num

GE Medical Systems, LLC

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

FDA Recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA Recall: Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

FDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

CareFusion 303, Inc.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

FDA Recall: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Medtronic MiniMed, Inc.

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

FDA Recall: Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Recall: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

FDA Recall: Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin

Tandem Diabetes Care, Inc.

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.

FDA Recall: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

FDA Recall: Philips L17-5 Ultrasound Transducer

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA Recall: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

FDA Recall: Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co

Navajo Manufacturing Company

If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.

FDA Recall: Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japanese-style fried rice made with c