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 2341–2360 of 38,428 recalls
Recalled Item: KliniTray Platte Faxitron
The Issue: for microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KliniTray. KlinioTray. Tissue resection margin examination board/small....
The Issue: for microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INSPIRA AIR BALLOON DILATION SYSTEM 10x40
The Issue: Incorrect product packaged in INSPIRA AIR Balloon Dilation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro
The Issue: Preset treatment parameters are not consistently being used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35
The Issue: for internal fastening mechanism within generator of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rover Product Name: Mobile X-ray System Model/Catalog Number:
The Issue: for internal fastening mechanism within generator of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atalante X
The Issue: for exoskeleton to lose lateral balance and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Posterior Femoral Augment
The Issue: The device was delivered with a preassembled Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Augment
The Issue: The device was delivered with a preassembled Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enhanced Verify Evaluation Handset (CFN HH90130FA)
The Issue: Evaluation handsets may not be able to communicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distal Femoral Augment
The Issue: The device was delivered with a preassembled Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L-Shaped Femoral Augment
The Issue: The device was delivered with a preassembled Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGEC 2 Rod
The Issue: Devices for the affected lot were not assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment
The Issue: Due to manufacturing issues, abutment products were manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Washer Disinfector Aquadis 56
The Issue: The frequency inverter is not programmed by supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Washer Disinfector Aquadis 56
The Issue: The frequency inverter is not programmed by supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HistoCore PELORIS 3
The Issue: There is a leakage issue associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: myQA iON
The Issue: Wrong analysis results can occur if the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance CT Big Bore
The Issue: Unintended motion issues related to Interventional Control that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72
The Issue: During routine preventative maintenance checks, it was revealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.