2026-07-27 to 2026-08-02
Sources: NHTSA, CPSC, FDA_DEVICE, FDA_FOOD, FDA_DRUG
Other Recalls
A separated ABS ECU may become damaged, causing the ABS system to fail and increasing the risk of a crash.
The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
A detached screw may lodge between the frame and stem, interfering with steering and increasing the risk of a crash or injury.
A fuel leak in the presence of an ignition source increases the risk of a fire.
The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire and burn hazards.
The ladder may detach during use, increasing the risk of injury.
An misfire or loss of drive power increases the risk of a crash.
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.
The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards.
The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and shock hazards.
People in an enclosed space, such as a garage, with a running generator may be at an increased risk of injury or death from carbon monoxide poisoning.
The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards.
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not stiff enough to safely slow a rider down and the kit design does not include an emergency brake, posing collision and fall hazards.
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
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.
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children may fall or land on a dive stick, resulting in serious piercing injuries. Facial and eye injuries are also possible when children attempt to retrieve the sticks underwater.
The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts, posing a deadly choking hazard.
The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. In addition, the products do not bear the warning labels required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
An improperly installed seat belt buckle anchor may fail to properly restrain occupants, increasing the risk of injury during a crash.
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Improper air bag deployment can increase the risk of injury during a crash.
Improper air bag deployment can increase the risk of injury during a crash.
An overheated conductor may increase the risk of a fire.
Incorrect tire pressure information can result in over inflated tires, increasing the risk of tire failure and a crash.
Contact with wiring may cause a short circuit or an electrical arc, increasing the risk of a fire.
An obstructed rearview camera image can reduce the driver's rear visibility, increasing the risk of a crash.
A cracked base may result in a loss of air pressure and suspension support, increasing the risk of a crash.
Detached trim pieces can create a road hazard, increasing the risk of a crash.
Ambient storage of the product may lead to Clostridium botulinum toxin formation.
Subpotent Drug
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in product
No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
Lack of Assurance of Sterility
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Subpotent Drug
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Lack of Assurance of Sterility
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.
Undeclared sodium tripolyphosphate (STTP)
Lack of Assurance of Sterility
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Moringa Powder ingredient positive for salmonella
Undeclared colors: Yellow#5, and Yellow#6.
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
Subpotent Drug
Subpotent Drug
Undeclared sodium tripolyphosphate (STTP)
Contaminated with Salmonella
Undeclared Allergen (Fish)
Subpotent Drug
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Subpotent Drug
Subpotent Drug
Undeclared sodium tripolyphosphate (STTP)
Lack of Assurance of Sterility
Subpotent Drug
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Subpotent Drug
Presence of Foreign Tablets/Capsules
Presence of Particulate Matter: Hair was found in products
Failed Dissolution Specifications
Subpotent Drug
Lack of Assurance of Sterility
Presence of Particulate Matter: Hair was found in products
Lack of Assurance of Sterility
Subpotent Drug
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Unapproved food additive: sassafras bark.
Subpotent Drug
Lack of Assurance of Sterility
Presence of Particulate Matter: Hair was found in products
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Lack of Assurance of Sterility
Due to manufacturing issues, reperfusion catheters may fractures
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Due to device not having FDA Clearance
Failed Impurities/Degradation Specifications
Brake lights that remain on may fail to alert other vehicles of the driver's intention, increasing the risk of a crash.
A loss of lighting, windshield wipers, ABS function, or a loss of drive power can increase the risk of a crash.
Brake lights that remain on may fail to alert other vehicles of the driver's intention, increasing the risk of a crash.
A vehicle rollaway increases the risk of a crash or injury.
Incorrect information may result in the wrong sized replacement tires being installed, increasing the risk of a crash.
An unsecured wheelchair can move during transit, increasing the risk of injury.