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 4721–4740 of 38,428 recalls

June 13, 2024· Steris Corporation

Recalled Item: Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide...

The Issue: IFU for hookup were incorrectly reflected within hookup

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

Class II — Potential Health HazardOngoing
June 13, 2024· Steris Corporation

Recalled Item: Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide...

The Issue: IFU for hookup were incorrectly reflected within hookup

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

Class II — Potential Health HazardOngoing
June 13, 2024· Steris Corporation

Recalled Item: Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide...

The Issue: IFU for hookup were incorrectly reflected within hookup

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

Class II — Potential Health HazardOngoing
June 13, 2024· Steris Corporation

Recalled Item: Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups...

The Issue: IFU for hookup were incorrectly reflected within hookup

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

Class II — Potential Health HazardOngoing
June 13, 2024· Hologic Inc

Recalled Item: Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A

The Issue: Non-conformance pertains to electromagnetic compatibility requirements according

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

Class II — Potential Health HazardOngoing
June 13, 2024· Baxter Healthcare Corporation

Recalled Item: Braun Thermoscan¿ PRO 6000 Ear Thermometer

The Issue: The Braun Thermoscan PRO 6000 ear thermometers may

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

Class II — Potential Health HazardOngoing
June 12, 2024· Boston Scientific Corporation

Recalled Item: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
June 12, 2024· Synergetics Inc

Recalled Item: BAUSCH+LOMB

The Issue: Sterilization certificates could not be validated by the

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

Class I — Serious Health HazardOngoing
June 12, 2024· Synergetics Inc

Recalled Item: BAUSCH+LOMB

The Issue: Sterilization certificates could not be validated by the

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

Class I — Serious Health HazardOngoing
June 12, 2024· Synergetics Inc

Recalled Item: BAUSCH+LOMB

The Issue: Sterilization certificates could not be validated by the

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

Class I — Serious Health HazardOngoing
June 12, 2024· Synergetics Inc

Recalled Item: BAUSCH+LOMB

The Issue: Sterilization certificates could not be validated by the

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

Class I — Serious Health HazardOngoing
June 11, 2024· Medical Action Industries, Inc. 306

Recalled Item: Foam Protective Pouches

The Issue: The protective pouches were identified to have been

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing