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 17581–17600 of 38,428 recalls

June 7, 2019· Burlington Medical, LLC

Recalled Item: 2 pc Full Wrap Vest & Kilt

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Kilt

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Sleeve

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Thyroid Collar

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Thyroid Collar Oversize

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Thyroid Collar

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: 2 pc Full Wrap Vest & Kilt Back-Saver

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Porta Shield

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Frontal Quick Drop OR Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Half Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Cap

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Peak Vest

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: 1 pc Full Wrap Support Belt Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Thyroid Collar

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Frontal Stretch Buckle Closure Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Centurion Medical Products Corporation

Recalled Item: Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

The Issue: Centurion is conducting a sub-recall for Teleflex Sheridan

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

Class I — Serious Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: 1 pc Full Wrap Back Relief Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Philips North America, LLC

Recalled Item: Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A

The Issue: The AC power module may fail at a

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

Class II — Potential Health HazardTerminated
June 6, 2019· Skeletal Kinetics, Llc

Recalled Item: OsteoVation

The Issue: A discrepancy was found between the Mixing Instruction

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

Class II — Potential Health HazardTerminated
June 6, 2019· Skeletal Kinetics, Llc

Recalled Item: OsteoVation

The Issue: A discrepancy was found between the Mixing Instruction

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

Class II — Potential Health HazardTerminated