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 37841–37860 of 38,428 recalls

April 20, 2012· Osteotech Inc

Recalled Item: Optimum Expanse R Grafton is a human bone allograft product

The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,

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

Class II — Potential Health HazardTerminated
April 20, 2012· Osteotech Inc

Recalled Item: Grafton DBM A-Flex Multiple Sizes Grafton is a human bone

The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,

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

Class II — Potential Health HazardTerminated
April 20, 2012· Osteotech Inc

Recalled Item: Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a

The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,

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

Class II — Potential Health HazardTerminated
April 19, 2012· Zimmer Biomet, Inc.

Recalled Item: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled

The Issue: failure of the optical distance sensor due

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

Class II — Potential Health HazardTerminated
April 19, 2012· Ge Healthcare It

Recalled Item: The GE Centricity Web

The Issue: GE Healthcare has become aware of an issue

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

Class II — Potential Health HazardTerminated
April 18, 2012· Bacterin International, Inc.

Recalled Item: Bacterin International

The Issue: Expired product was shipped to two customers

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Secondary Administration Kit...

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Standard Administration Kit...

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 18, 2012· Medrad Inc

Recalled Item: Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System

The Issue: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF

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

Class II — Potential Health HazardTerminated
April 17, 2012· ICU Medical, Inc.

Recalled Item: 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock

The Issue: The firm initiated the recall due to a

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

Class II — Potential Health HazardTerminated
April 17, 2012· ICU Medical, Inc.

Recalled Item: High Pressure Stopcock (3-Way

The Issue: The firm initiated the recall due to a

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

Class II — Potential Health HazardTerminated
April 17, 2012· ICU Medical, Inc.

Recalled Item: Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

The Issue: The firm initiated the recall due to a

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

Class II — Potential Health HazardTerminated