A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
All Recalls
95,018 total recalls in our database
Exposed to freezing temperatures due to refrigerated truck malfunctions
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Exposed to freezing temperatures due to refrigerated truck malfunctions
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Gentherm Medical
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
Exposed to freezing temperatures due to refrigerated truck malfunctions
SoftCytogenetics
Soft Computer Consultants
Software is given wrong results going out to HIS on test that had reruns.
ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
Mckesson Medical-Surgical Inc. Corporate Office
Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Dutch Ophthalmic USA
Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
Birkenstock Kids' Mogami Sandals Sizes 24-28
Unknown Manufacturer
A plastic rivet can detach from the sandal's ankle strap, posing a choking hazard for young children.
Children's Pajamas
Tkala Fashion, of Shenzen, China
The pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Removable Foam Facial Interfaces for Oculus Quest 2 Virtual Reality Headsets
Unknown Manufacturer
The foam facial interfaces can cause facial skin irritation and reactions including rashes, swelling, burning, itching, hives, and bumps.
Barrington 5-Drawer Chests
Unknown Manufacturer
The recalled chests are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries to children. The chests do not comply with the performance requirements of the voluntary industry standard ASTM F2057-14.
Model Years 2020 and 2021 Can-AM Defender HD10 side-by-side vehicles
Unknown Manufacturer
The stock CVT air intake can become completely obstructed with snow causing the drive belt to overheat and break, posing a fire hazard.