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 21121–21140 of 38,428 recalls

April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Tibial Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Roche Diagnostics Corporation

Recalled Item: Elecsys Vitamin D total II

The Issue: The device may give a falsely elevated result

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

Class II — Potential Health HazardTerminated
April 27, 2018· Roche Diagnostics Corporation

Recalled Item: Elecsys Vitamin D total II

The Issue: The device may give a falsely elevated result

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

Class II — Potential Health HazardTerminated
April 26, 2018· Horiba Instruments, Inc dba Horiba Medical

Recalled Item: ABX Pentra Micro ALBUMIN 2 CP

The Issue: When the ABX Pentra Micro ALBUMIN 2 CP

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm -

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· Draeger Medical, Inc.

Recalled Item: Carina Ventilator

The Issue: The valve assembly material may become corroded due

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated