2026-06-29 to 2026-07-05
Sources: CPSC, NHTSA, FDA_FOOD, FDA_DRUG, FDA_DEVICE
Other Recalls
The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard.
The recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards.
The recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
The recalled LED finger lights violate the mandatory safety standard for toys because they 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.
The lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns and death.
The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.
The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing a choking hazard.
The recalled lithium-ion battery in the vacuum cleaner can overheat and ignite, posing a risk of serious injury from fire and burn hazards.
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows?and infant support cushions because they can obstruct an infant's breathing, posing a serious risk of injury or death from suffocation.
The recalled baby loungers violate the mandatory safety standard for?infant sleep products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.
The electrical system may overheat without a ground, increasing the risk of a fire. There is also an increased risk of injury from electrical shock.
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
The recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury from explosion and burn hazards.
A vehicle that does not make a sound may fail to alert pedestrians of an approaching vehicle, increasing the risk of a crash or injury.
An instrument panel display that does not show critical information, such as gear selection, increases the risk of a crash.
Potential Salmonella contamination
Potential Salmonella contamination
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Non-Sterility: Due to presence of Aspergillus penicillioides.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Software anomaly that causes a false display of error code 5018.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Product not adequately pasteurized
Improperly eviscerated which may result in Clostridium botulinum contamination
Potential presence of Salmonella.
Undeclared allergen, sesame.
Potential presence of Salmonella.
Potential presence of Salmonella.
potential salmonella contamination
Product not adequately pasteurized
Potential Salmonella contamination
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Potential Salmonella contamination.
Product not adequately pasteurized
Product not adequately pasteurized
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich
Product not adequately pasteurized
Potential presence of Salmonella.
Product not adequately pasteurized
Product not adequately pasteurized
Product not adequately pasteurized
Potential Salmonella contamination
Product not adequately pasteurized
Potential Salmonella contamination
Product not adequately pasteurized
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
Potential Salmonella contamination
Potential presence of Salmonella.
Potential Salmonella contamination
Undeclared allergens: Milk and Soy
Potential Salmonella contamination
Product not adequately pasteurized
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Potential Salmonella contamination
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Potential Salmonella contamination.
Product not adequately pasteurized
Potential presence of Salmonella.
Product not adequately pasteurized
Product not adequately pasteurized
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Presence of Foreign Substance.
Presence of Foreign Substance.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CGMP Deviations
CGMP Deviations
sub potency
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Incorrect product formulation: bag did not contain copper and famotidine per label.
Subpotent Drug
Lack of Assurance of Sterility
Presence of foreign substance
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
CGMP Deviations
CGMP Deviations
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Potential for thrombus formation during prolonged use of the introducer.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Potential for thrombus formation during prolonged use of the introducer.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Potential for thrombus formation during prolonged use of the introducer.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Potential for thrombus formation during prolonged use of the introducer.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
A missing gear selection indicator may lead to unintended vehicle movement or a vehicle rollaway, increasing the risk of a crash.
An overheated printed circuit board increases the risk of a fire.
A dinette that moves during transit may increase the risk of injury.
Referencing incorrect weight information may lead to unintentionally overloading the vehicle, increasing the risk of a crash.
A vehicle that does not produce a warning sound may fail to alert pedestrians of an approaching vehicle, increasing the risk of injury.
Windshield wipers or a washing system that fails to function as intended can reduce visibility, increasing the risk of a crash.
Differential pinion shaft fracture may result in a loss of drive power, or unintended vehicle movement if the vehicle is in park without the parking brake applied, increasing the risk of a crash.
An unexpected loss of drive power can increase the risk of a crash. In addition, a driveshaft that is not fully engaged can result in a vehicle rollaway if the parking brake is not applied, increasing the risk of a crash or injury.