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 35681–35700 of 38,428 recalls
Recalled Item: Siemens AXIOM Artis zeego x-ray
The Issue: Siemens issued a customer safety notice about the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems
The Issue: It has been confirmed from in-house testing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFX" Introducer System
The Issue: Endologix, Inc. initiated this voluntary recall of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister
The Issue: Ethicon Endo-Surgery is initiating a voluntary worldwide recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digitex Absorbable Polydiaxanone Suture
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600
The Issue: MedCare Products has determined that a number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo(R) Lab Data Manager - Version VA11B and VA12A Systems
The Issue: Under certain conditions the system may not perform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Responder 5 is a nurse call communication system that connects
The Issue: A counterfeited electronic component was identified in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 3i Dental Implant
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 3i Dental Implant
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invue Split Driver
The Issue: Device design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE Systems Third Generation TSH ( - 100T
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems TSH3 Ultra ReadyPack (( - 100 Tests
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension EXL LOCI Module TSHL Flex Reagent Cartridge ().
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista System TSH Flex Reagent Cartridge (). Intended
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension TSH Flex Reagent Cartridge (). Intended to quantitatively
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE Systems Rapid TSH ( - 100T
The Issue: A rare variant of TSH, identified in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part 510449 Disposable Infusion Pump
The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part 510636 Disposable Infusion Pump
The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part 510180 Disposable Single Infusion Pump
The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.