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 31921–31940 of 38,428 recalls

October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Biomet Microfixation, LLC

Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti

The Issue: Laser etching on the parts is wider and

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

Class II — Potential Health HazardTerminated
October 17, 2014· Ethicon, Inc.

Recalled Item: Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet

The Issue: Ethicon is unable to ensure that PERMA-HAND silk

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

Class II — Potential Health HazardTerminated
October 17, 2014· Remel Inc

Recalled Item: Oxoid Legionella BCYE Growth Supplement SR0110A

The Issue: Recalled product may not provide adequate recovery of

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

Class II — Potential Health HazardTerminated
October 17, 2014· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Rapid Neg Urine Combo Panel Type 1

The Issue: An increase in false positive susceptible results on

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

Class I — Serious Health HazardTerminated
October 17, 2014· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide

The Issue: Cardiohelp- i System may have a software issue

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

Class II — Potential Health HazardTerminated
October 17, 2014· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Rapid Neg BP Combo Panel Type 3

The Issue: An increase in false positive susceptible results on

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

Class I — Serious Health HazardTerminated
October 16, 2014· Diagnostic Hybrids Inc

Recalled Item: MicroVue Bb Plus EIA is packaged as a kit which

The Issue: Samples are quantitating incorrectly, with approximately 50% higher

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

Class II — Potential Health HazardTerminated
October 16, 2014· Skeletal Dynamics

Recalled Item: Align Radial Stems

The Issue: Report received where the Align Radial Stem fractured

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

Class II — Potential Health HazardTerminated
October 16, 2014· Materialise USA LLC

Recalled Item: Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and

The Issue: The box of guides for a specific case

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

Class II — Potential Health HazardTerminated
October 16, 2014· Biomerieux

Recalled Item: Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility...

The Issue: The products have a wrong expiration date on

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

Class III — Low RiskTerminated
October 16, 2014· Biomerieux

Recalled Item: Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility...

The Issue: The products have a wrong expiration date on

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

Class III — Low RiskTerminated
October 16, 2014· Biomerieux

Recalled Item: Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility...

The Issue: The products have a wrong expiration date on

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

Class III — Low RiskTerminated
October 16, 2014· Biomerieux

Recalled Item: Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility...

The Issue: The products have a wrong expiration date on

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

Class III — Low RiskTerminated
October 16, 2014· Biomerieux

Recalled Item: Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility...

The Issue: The products have a wrong expiration date on

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

Class III — Low RiskTerminated