Consumer Product Recalls

Hazard: The incorrect thrust bearings can cause the axel shaft to break and a loss of vehicle control, increasing the risk of a crash.

Hazard: A rearview image that does not display reduces the driver's visibility, increasing the risk of a crash.

Hazard: A rearview image that does not display reduces the driver's visibility, increasing the risk of a crash.

Hazard: The tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.

Hazard: The drawstring in the hood of the recalled jackets can get caught on objects and cause death or serious injury to children due to the strangulation hazard. The jackets are in violation of the federal regulations for children's upper outerwear and present a substantial product hazard.

Hazard: The recalled 6-in-1 Pounding Game violates the mandatory federal regulation for magnets because it contains a magnet that can become loose, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.

Hazard: The recalled resin menorahs can burn or catch fire when holding lit candles, posing a fire hazard.

Hazard: The lithium-ion battery in the recalled portable lamps can overheat while charging, posing fire and burn hazards to consumers.

Hazard: The recalled children's pajamas violate the federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

Hazard: The climbing ropes can weaken and break, posing a fall hazard to consumers.

Hazard: The CO2 cartridge can be unintentionally ejected with force from the handle, posing an impact hazard.

Hazard: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

Hazard: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

Hazard: Due to devices being irradiated above the established specification which my result in package integrity issues.

Hazard: Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

Hazard: Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.

Hazard: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.

Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Hazard: Due to nasal spray stability failure for bioburden.

Hazard: During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

Hazard: During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

Hazard: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

Hazard: Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

Hazard: Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

Hazard: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Hazard: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.