Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 5841–5860 of 38,428 recalls
Recalled Item: Bed Assist Bars
The Issue: Medline is recalling certain lots of our Adult
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bed Assist Bars
The Issue: Medline is recalling certain lots of our Adult
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom PRO+ 36" MRS Surface
The Issue: Inconsistencies were identified with service records associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiCross Coronary Imaging Catheter
The Issue: Certain batches of Opticross 40MHz Coronary Imaging Catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product
The Issue: The expiration date was not printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product
The Issue: The expiration date was not printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product
The Issue: The expiration date was not printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235
The Issue: There is a risk of mistreatment as irradiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ2 Connect MDx-IVD Designed to perform automated isolation and purification
The Issue: Insufficient welding leads to the heater cable becoming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Anti-HCV Reagent Kit
The Issue: Customer complaints were received regarding falsely elevated results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Guide Handpiece Adaptor Sleeve 3
The Issue: The Handpiece Adaptor may have a manufacturing defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Guide Handpiece Adaptor Sleeve 1
The Issue: The Handpiece Adaptor may have a manufacturing defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Anti-HCV Reagent Kit
The Issue: Customer complaints were received regarding falsely elevated results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 25-LHP-928
The Issue: These laser products fail to comply with 21
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: N-LHP-928
The Issue: These laser products fail to comply with 21
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 25-LHP-828
The Issue: These laser products fail to comply with 21
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus
The Issue: Due to increase in complaints for the KD-640L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus
The Issue: Due to increase in complaints for the KD-640L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs...
The Issue: for positively biased results due to signal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits
The Issue: Trumpet Needle Guide ring can detach when excessive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.