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 9661–9680 of 38,428 recalls

October 21, 2022· Busse Hospital Disposables, Inc.

Recalled Item: Busse SPINE INJECTION TRAY-Intended as a nerve block . 8563R1

The Issue: Kits containing 3M Steri-Drape Surgical Drapes recalled by

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

Class II — Potential Health HazardOngoing
October 21, 2022· Howmedica Osteonics Corp.

Recalled Item: Simplex HV With Gentamicin CE

The Issue: Simplex HV With Gentamicin CE, 10 PACKS (P/N

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 MAJOR EAR

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 ACDF

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· CoreLink LLC

Recalled Item: CoreLink LLC

The Issue: Specific lots of FLXfit implants have internal components

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

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

Recalled Item: regard SPINE

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 HIP 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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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 SPINE

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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 CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY

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 CERVICAL 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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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 ACDF

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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· Remel Inc

Recalled Item: Thermo SCIENTIFIC

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 FOOT PACK - MERCY SPRINGFIELD

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