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 9681–9700 of 38,428 recalls

October 20, 2022· Remel Inc

Recalled Item: Thermo SCIENTIFIC Sensititre Plate

The Issue: An internal technical investigation has confirmed that Thermo

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

Class I — Serious Health HazardTerminated
October 20, 2022· ROi CPS LLC

Recalled Item: regard DAVINCI PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard BASIC NEURO

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard RETINAL PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard NEURO PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard BASIC NEURO

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard SPINE PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard SHOULDER PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard SHOULDER W BCH CHAIR

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard TOTAL HIP ARTHROPLASTY A&B

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard MINOR NEURO

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard SHOULDER

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard FOOT PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard SHOULDER ARTHROSCOPY

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard LATERAL SHOULDER

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard TOTAL JOINT

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard HAND PACK

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: ¿regard SHOULDER ARTHROSCOPY

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard CATARACT

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing
October 20, 2022· ROi CPS LLC

Recalled Item: regard CATARACT

The Issue: Surgical convenience kits were distributed containing 3M surgical

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

Class II — Potential Health HazardOngoing