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 21001–21020 of 38,428 recalls
Recalled Item: Space Pump IV Set
The Issue: There is a potential for a different set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImagePilot
The Issue: Panasonic has issued a Mandatory Product Safety Notice,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Logic CC Stem Extension
The Issue: Potentially have non-conforming internal threads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and
The Issue: Elevated false positive results Yersinia enterocolitica (Yersinia) from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Resuscitation Device
The Issue: An error in manufacturing of the AirLife Resuscitation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Resuscitation Device
The Issue: An error in manufacturing of the AirLife Resuscitation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivo 65
The Issue: Some Vivo 65 devices have an unreleased version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX-10 surveillance laser system Product Usage: The expected usage of
The Issue: Product has a nominal ocular hazard distance (NOHD)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed HARMONIC Ace¿ +7
The Issue: Stryker Sustainability Solutions has received an increase in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Observer SD
The Issue: In certain eyepiece configurations the laser shutter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
The Issue: The firm will be updating the Instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
The Issue: The firm will be updating the Instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA(TM) Robotized Stereotactic Assistant
The Issue: Replacement of units lacking an updated device approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynarex CGA870 All Brass Oxygen Regulator
The Issue: The device is equipped with a dial that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WaveCrest Left Atrial Appendage (LAA)
The Issue: When attempting to recapture the 32-mm device, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLENE SUTURE 36"(90CM) 4-0 BLUE
The Issue: The needle associated with certain suture product codes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas m 511 integrated hematology analyzer
The Issue: Discrepant results have been reported in patients with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C
The Issue: The needle associated with certain suture product codes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLENE SUTURE BLUE 18" 7-0 D/A BV-1
The Issue: The needle associated with certain suture product codes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C
The Issue: The needle associated with certain suture product codes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.