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 27821–27840 of 38,428 recalls
Recalled Item: cobas p 512 pre-analytical system Pre-analytical sample handling that includes
The Issue: Due to a false triggering or detection of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Short Percutaneous Antenna with Thermosphere" Technology Standard...
The Issue: Medtronic is voluntarily recalling specific item codes and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Video Duodenoscope
The Issue: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:...
The Issue: Innovative Ophthalmic Products (IOP) is recalling the Molteno
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioTex Reusable Adapter Kit
The Issue: Medtronic Navigation is recalling the Biotex Adapter Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo: Models: 9784000131
The Issue: The analysis showed that the incident was caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juno DRF
The Issue: The analysis showed that the incident was caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine
The Issue: The analysis showed that the incident was caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine
The Issue: The analysis showed that the incident was caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sure Vue Color Staph 150T
The Issue: Customer complaints of very weak reactions with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400
The Issue: Horiba Instruments, Inc. is recalling ABX Pentra 400(
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA
The Issue: Horiba Instruments, Inc. is recalling ABX Pentra 400(
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink iPro2 Reports
The Issue: Medtronic MiniMed is recalling 19 CareLink iPro Therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha
The Issue: Software issues on Cios Alpha mobile C-Arm system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego (system
The Issue: leak in the cooling system, fluids could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis (system
The Issue: leak in the cooling system, fluids could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.