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 4121–4140 of 38,428 recalls
Recalled Item: MAKO Integrated Cutting System (MICS) HANDPIECE
The Issue: Stryker has identified an issue with the characterization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacemaker
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hand Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaginal Delivery
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IR Procedure Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nasal Sinus Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PACEMAKER PACK
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuro Vascular
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endovascular AAA Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bilateral Tubal Ligation Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paracentesis Thoracente
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cath Lab Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PT301US Airvo 3 Respiratory Support Device with software version 1.2.0
The Issue: Due to a software issue, affected devices that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endovascular AAA Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shoulder
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.