2026-08-31 to 2026-09-06
Sources: FDA_FOOD, CPSC, FDA_DRUG, FDA_DEVICE, NHTSA
Other Recalls
Potential to be contaminated with Listeria monocytogenes
Products contain undeclared yohimbine
Potential to be contaminated with Salmonella
Presence of particulate matter and lack of sterility assurance
The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
The lithium-ion batteries in the Cambridge Audio Yoyo (M) Portable Bluetooth Speaker can overheat, posing a fire hazard.
The black eyes can detach from the recalled teether if frozen, posing a risk of serious injury or death from a choking hazard.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails also do not meet retention strap requirements, posing a fall hazard. The bed rails’ push pins and push pin holes are incorrectly sized, posing a laceration hazard. In addition, the bed rails do not bear the required hazard warning labels.
The squeezy toys contain water beads. If ingested, water beads expand and can pose deadly ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration, and a risk of death to a child.
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 backrests of the chairs can detach, posing a fall hazard to consumers.
The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
The recalled products may contain bacteria, including Pseudomonas aeruginosa, which is an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.
The affected handlebars may crack or fracture during use, which can lead to loss of control, posing a risk of serious injury or death from fall hazard.
The toys violate the small ball ban because they contain small balls and are intended for children under three years of age, posing a deadly choking hazard.
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.
Possible E. Coli Contamination
Presence of particulate matter identified as iron oxide
Undeclared peanuts.
Foreign object: products may contain glass pieces
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
Subpotent Drug
Foreign object: products may contain glass pieces
Foreign object: products may contain glass pieces
Subpotent Drug
Product may have been improperly pasteurized.
Failed content uniformity specifications.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Potential Salmonella Javiana contamination
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Software issue may cause the ruler measurement to be inaccurate.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Kits contain a potentially contaminated component which were recalled by the manufacturer
Subpotent Drug
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Subpotent Drug
Subpotent Drug
Kits contain a potentially contaminated component which were recalled by the manufacturer
Label does not declare walnuts in English
Software issue may cause measurements to be displayed inaccurately.
Subpotent Drug
Presence of particulate matter: glass and stopper piece
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Subpotent Drug
Foreign object: products may contain glass pieces
A liftgate that falls unexpectedly increases the risk of injury.
Delayed brake response time can increase the risk of a crash.
A wheelchair lift that continues to move while occupied increases the risk of injury.
A detach light tower can become a road hazard for other vehicles, increasing the risk of a crash or injury.
Unvented exhaust fumes increase the risk of injury from carbon monoxide poisoning.
The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
Label does not declare walnuts in English
Label does not declare walnuts in English
Subpotent Drug
Subpotent Drug
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Foreign object: products may contain glass pieces
Subpotent Drug
Subpotent Drug
Subpotent Drug
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
Product has the potential to be spoiled.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Undeclared peanuts.
Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list
Kits contain a potentially contaminated component which were recalled by the manufacturer
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Component labeling discrepancy
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Test manufactured with an expired ingredient which may present as either a false negative or positive.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Potential of failing to trigger clinical scan during Bolus Tracking.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Kits contain a potentially contaminated component which were recalled by the manufacturer
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Rear coil springs that detach from the vehicle while driving increase the risk of a crash.
A lateral link separation could shift the wheel alignment, causing a loss of vehicle control and increasing the risk of a crash.
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
A loss of electronic stability control increases the risk of a crash.
LP tanks that cannot be shut off increase the risk of a fire. Additionally a loose LP tank may detach and become a road hazard, increasing the risk of a crash.
A wheelchair lift that continues to move while occupied increases the risk of injury.
The incorrect warning light may fail to alert the driver to critical safety information or cause confusion, increasing the risk of a crash.
Incorrect information may result in the wrong sized replacement tires being installed, increasing the risk of a crash.
A detached winch may increase the risk of injury to people near the trailer.
Undeclared milk
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Contains garlic essential oil not approved for culinary use