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 37401–37420 of 38,428 recalls

July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: KIT

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: KIT

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: ACCESSORY BASE STARTER KIT

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: KIT

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: KIT

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Intuitive Surgical, Inc.

Recalled Item: INSTRUMENT ARM DRAPE IS2000

The Issue: Specific lots of the Instrument Arm Drapes were

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

Class II — Potential Health HazardTerminated
July 13, 2012· Hospira Inc.

Recalled Item: Hospira LifeShield Latex-Free 100 mL Burette Set

The Issue: The float valve in the burette sticks to

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

Class II — Potential Health HazardTerminated
July 13, 2012· Westone Laboratories, Inc.

Recalled Item: Oto Ease by Westone

The Issue: Westone is recalling all Oto Ease ear lubricant

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

Class II — Potential Health HazardTerminated
July 12, 2012· GE Healthcare, LLC

Recalled Item: GE Healthcare

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
July 12, 2012· Alere San Diego, Inc.

Recalled Item: Alere Triage TOX Drug Screen 9 Panel

The Issue: Alere San Diego is recalling Alere Triage TOX

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

Class II — Potential Health HazardTerminated
July 12, 2012· Aesculap Implant Systems LLC

Recalled Item: Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD

The Issue: The 4 degree and 9 degree trial instruments

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

Class II — Potential Health HazardTerminated
July 11, 2012· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B.

The Issue: In certain situations, loss of post exercise images

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

Class II — Potential Health HazardTerminated
July 11, 2012· Philips Healthcare Inc.

Recalled Item: Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642

The Issue: Inclination switch in the stand may have been

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

Class II — Potential Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: Safe Spot Infant Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: Safe Spot Infant Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: AirFlow Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: V*Care Resuscitator Infant Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: Adult Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: Ventlab Rescue Med Infant Resuscitator

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated
July 11, 2012· Ventlab Corporation

Recalled Item: AirFlow

The Issue: volume leakage through the inlet valve during

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

Class I — Serious Health HazardTerminated