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.

38,428 total recalls
0 this month

Showing 7261–7280 of 38,428 recalls

August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCurity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCurity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· Stryker Medical Division of Stryker Corporation

Recalled Item: ProCuity bed series

The Issue: Patient beds are missing test values for electrical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· RoyalVibe Health Ltd.

Recalled Item: CellQuicken Analyzer (Smart-Watch and Software)

The Issue: Ultrasound devices were not authorized, cleared, or approved

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· AB Sciex, LLC

Recalled Item: Citrine Triple Quad Mass Spectrometer

The Issue: In rare occasions, the combination of a leak

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· AB Sciex, LLC

Recalled Item: 4500MD Triple Quad Mass Spectrometer

The Issue: In rare occasions, the combination of a leak

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· AB Sciex, LLC

Recalled Item: API3200MD Mass Spectrometer

The Issue: In rare occasions, the combination of a leak

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 30, 2023· AB Sciex, LLC

Recalled Item: Citrine QTRAP Mass Spectrometer

The Issue: In rare occasions, the combination of a leak

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· CooperSurgical, Inc.

Recalled Item: Box as labeled: Regard

The Issue: Incorrect component descriptions within the "Contents" section on

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· Limacorporate S.p.A

Recalled Item: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates:...

The Issue: for baseplate peripheral holes to be out

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Recalled Item: Arjo medical beds

The Issue: Unintended movement of bed wheels

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Recalled Item: Arjo medical beds

The Issue: Unintended movement of bed wheels

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· Flower Orthopedics Corporation

Recalled Item: Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream

The Issue: Device is breaking while in use, potential for

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 29, 2023· Becton Dickinson Infusion Therapy Systems Inc.

Recalled Item:

The Issue: There is the potential that the safety shield

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 25, 2023· Immunostics, Inc.

Recalled Item: Detector H. Pylori

The Issue: Labeling for affected lots incorrectly indicates the expiration

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing