🏥 Medical Devices Class I - Dangerous
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
FDA revocation of the Emergency Use Authorization due to performance issues
🏥 Medical Devices Class I - Dangerous
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
🏥 Medical Devices Class I - Dangerous
FDA revocation of the Emergency Use Authorization due to performance issues
🏥 Medical Devices Class I - Dangerous
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
🏥 Medical Devices Class I - Dangerous
The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.
🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
🏥 Medical Devices Class I - Dangerous
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
🏥 Medical Devices Class I - Dangerous
Modular Junction Box (MJB) cables can melt and affect the bed functionality.
🏥 Medical Devices Class I - Dangerous
FDA revocation of the Emergency Use Authorization due to performance issues
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
🏥 Medical Devices Class I - Dangerous
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Standoff and Wide Dock Ladders
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The edges on the side of the steps are sharp and can cut consumers, posing a laceration hazard.
6" Plush Aflac Promotional Doctor Duck
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The buttons on the lab coat worn by the Doctor Duck contain levels of lead that exceed the federal lead content standard. Lead is toxic if ingested by young children and can cause adverse health issues.
Children's helmets
Aurorasports Ltd., of China
🏠 Consumer Products Class II - Moderate
The recalled helmets do not meet the federal safety standard, posing a risk of head injury.
🍎 Food Class I - Dangerous
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
🍎 Food Class I - Dangerous
The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.
🍎 Food Class I - Dangerous
Product contains undeclared milk
Kouign-Amann Pastry available in plastic clamshell 4-packs with Whole Foods Market scale labels, a PLU code 26739400000
Whole Foods Market
🍎 Food Class I - Dangerous
Potential to contain undeclared eggs
🍎 Food Class I - Dangerous
May contain undeclared milk