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 20421–20440 of 38,428 recalls
Recalled Item: da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply
The Issue: Certain Redundant Medical Grade Power Supply (RMGPS) units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cesar Powerpack-Visub(V3000)
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper F020 DR Table
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper F020 Biplane DR Table
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cesar-DMCP-Visub(HM2000/3000)
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXperFOlO/lO
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRIS Allura 15-12 (biplane)
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRIS Allura 9 F FDXD
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIIuraXperFDlO
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD2O Biplane
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper F010
The Issue: There is a potential for the Monitor Ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDLab 1265 Blood Gas Analyzer
The Issue: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDLab 1245 Blood Gas Analyzer
The Issue: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The
The Issue: Sample material may potentially come in contact with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Blood Gas Analyzer
The Issue: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 405 Blood Gas Analyzer
The Issue: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoLink(TM) Lapidus Plate XP
The Issue: CoLink(TM) Lapidus Plate +2mm Right and Left, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoLink(TM) Lapidus Plate XP
The Issue: CoLink(TM) Lapidus Plate +2mm Right and Left, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
The Issue: Immersion time stated on the bottle is 45
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G8 Automated HPLC Analyzer - 723G8 Product Usage - In
The Issue: Analyzers were distributed with software which lacks a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.