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 31821–31840 of 38,428 recalls

November 4, 2014· Aircraft Medical Limited

Recalled Item: McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items

The Issue: The blade retaining clip may be difficult to

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

Class II — Potential Health HazardTerminated
November 4, 2014· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView product code: 882478 BrightView X product code: 882480 BrightView

The Issue: Software issues

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

Class II — Potential Health HazardTerminated
November 4, 2014· Novadaq Technologies, Inc.

Recalled Item: LUNA Chest

The Issue: Mislabeling

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

Class III — Low RiskTerminated
November 4, 2014· Novadaq Technologies, Inc.

Recalled Item: Non-sterile drape

The Issue: Mislabeling

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

Class III — Low RiskTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM PERMANENT CAUTERY HOOK

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Zimmer CAS

Recalled Item: PSI Knee System- Prosthesis

The Issue: Internal discovery found that the MRI scans in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Bard Access Systems

Recalled Item: GuardIVa Antimicrobial Hemostatic IV Dressing

The Issue: Bard Access Systems is recalling GuardIVa (Ref. No

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM RESANO FORCEPS

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM MONOPOLAR CURVED SCISSORS

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated
November 3, 2014· Intuitive Surgical, Inc.

Recalled Item: 8MM FENESTRATED BIPOLAR FORCEPS

The Issue: Deviations in reprocessing steps from those stated in

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

Class II — Potential Health HazardTerminated