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 28901–28920 of 38,428 recalls

November 16, 2015· Ameditech Inc

Recalled Item: ProScreen 6 Panel Dip Card w/Adult (AU)

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: ProScreen 12 Panel Dip Card

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: ImmuTest 12 Panel Dip Card

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: ProScreen CLIA Wvd 12 Panel Cup w/Adult.

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: RealityCHECK Tilt Cup 12 Panel + Adult

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: iCup DX 11 Panel w/ Adulterant

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: DrugSmart 9 Test Cup (BUP)

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: ProScreen CLIA Waived Cup 6 Drugs w/Adul

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: 6 Panel Cup Body and Lid w/Adult (AU)

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: EDI BZO Uncut Sheet - Cup*

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 16, 2015· Ameditech Inc

Recalled Item: ProScreen 6 Panel Cassette w/Adult (AU)

The Issue: Ameditechs Drugs of Abuse Tests listed above have

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

Class III — Low RiskTerminated
November 13, 2015· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Maquet HCU 30 Coolant Type R134A Filling weight 250 g

The Issue: Failure of the HEATER-COOLER UNIT (HCU 30) Type

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

Class II — Potential Health HazardTerminated
November 13, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
November 13, 2015· Edwards Lifesciences, LLC

Recalled Item: Intravascular (IV) Administration Sets

The Issue: Edward Lifesciences is recalling Intravascular (IV) Administration Sets

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

Class II — Potential Health HazardTerminated
November 13, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
November 13, 2015· STERILMED, INC.

Recalled Item: Zimmer

The Issue: Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed

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

Class II — Potential Health HazardTerminated
November 12, 2015· Corflex

Recalled Item: CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative...

The Issue: Knee brace could fail to maintain the locked

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

Class II — Potential Health HazardTerminated
November 12, 2015· Corflex

Recalled Item: BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087...

The Issue: Knee brace could fail to maintain the locked

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

Class II — Potential Health HazardTerminated
November 12, 2015· Corflex

Recalled Item: Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee

The Issue: Knee brace could fail to maintain the locked

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

Class II — Potential Health HazardTerminated
November 12, 2015· Corflex

Recalled Item: ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231...

The Issue: Knee brace could fail to maintain the locked

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

Class II — Potential Health HazardTerminated