Consumer Product Recalls

Hazard: A loose child seat anchor bolt increases the risk of injury to a child during a crash.

Hazard: A monitor failing to display the correct image reduces the driver's view, increasing the risk of a crash.

Hazard: Trailer instability can cause a loss of control, increasing the risk of a crash.

Hazard: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

Hazard: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Hazard: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Hazard: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Hazard: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Hazard: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Hazard: A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

Hazard: A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Hazard: A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Hazard: An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.

Hazard: Software issue that could potentially lead to the device tipping over from Balance Mode.

Hazard: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

Hazard: Due to non-sterile products being labeled as sterile

Hazard: The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.

Hazard: Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

Hazard: Contact lens insertion solution may lack sterility.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: Sterility assurance for Ophthalmic knives.

Hazard: It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

Hazard: Product may have an off color affecting perfomance

Hazard: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

Hazard: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.