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 18641–18660 of 38,428 recalls

March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· Medtronic Vascular

Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER

The Issue: There is a potential for extensive loss of

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

Class I — Serious Health HazardCompleted
March 15, 2019· GE Healthcare, LLC

Recalled Item: Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat

The Issue: The bedside panels and latch areas on the

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

Class I — Serious Health HazardTerminated
March 15, 2019· GE Healthcare, LLC

Recalled Item: Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat

The Issue: The bedside panels and latch areas on the

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

Class I — Serious Health HazardTerminated
March 15, 2019· Roche Diagnostics Corporation

Recalled Item: cobas e 801 immunoassay analyzer

The Issue: The firm has confirmed complaints regarding signal drops

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

Class II — Potential Health HazardTerminated
March 15, 2019· Cytocell Ltd.

Recalled Item: Aquarius CSF1R/RPS14 (5q32-q33) Probe Red

The Issue: There is an error in the chromomap included

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

Class III — Low RiskTerminated
March 15, 2019· bioMerieux, Inc.

Recalled Item: Biomerieux Vitek 2 Test kit VITEK 2 is an automated

The Issue: E. coli Contamination

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

Class II — Potential Health HazardTerminated
March 15, 2019· GE Healthcare, LLC

Recalled Item: Innova IGS 6

The Issue: There is a potential for loss of the

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

Class II — Potential Health HazardOngoing
March 15, 2019· GE Healthcare, LLC

Recalled Item: Innova IGS 630

The Issue: There is a potential for loss of the

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

Class II — Potential Health HazardOngoing
March 15, 2019· GE Healthcare, LLC

Recalled Item: Innova IGS 630

The Issue: There is a potential for loss of the

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

Class II — Potential Health HazardOngoing
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage:

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated