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 3101–3120 of 38,428 recalls

December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Karl Storz Endoscopy

Recalled Item: Karl Storz - Endoskope - - Optical Biopsy and Grasping Forceps

The Issue: Due to failure of manual cleaning validation, biopsy

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 19, 2024· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Due to increased complaints regarding frayed or broken

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

Class II — Potential Health HazardOngoing
December 18, 2024· Instrumentation Laboratory

Recalled Item: HemosIL Heparin Calibrators

The Issue: Control indicating lower than expected quality control (QC)

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Brivo NM 615

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog...

The Issue: for inadvertent retention of biomaterial when the

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

Class I — Serious Health HazardOngoing