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 37801–37820 of 38,428 recalls

May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical M5C5/ MARK5 NUVO/STD

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical MARK5 NUVO 8 /OCSI

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical MARK5 NUVO 8 STD

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical NUVO LITE MODEL 925 OCSI

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical M5C5/ MARK5 NUVO/OCSI

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical NUVO LITE MODEL 525 OCSI

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical MARK5 NUVO / M5C5

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical NUVO LITE MODEL 925 OCSI

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
May 1, 2012· Nidek Medical Products Inc

Recalled Item: NIDEK Medical NUVO LITE MODEL 520 STD

The Issue: Capacitor failure may result in a fire hazard

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

Class I — Serious Health HazardTerminated
April 30, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Uroskop Access. Fluoroscopic

The Issue: Siemens has discovered a possible hazard to patients

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

Class II — Potential Health HazardTerminated
April 30, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray

The Issue: During regular product monitoring, firm became aware of

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

Class II — Potential Health HazardTerminated
April 30, 2012· Zimmer Inc.

Recalled Item: Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor

The Issue: The design of the spring clip for the

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

Class II — Potential Health HazardTerminated
April 30, 2012· Zimmer Inc.

Recalled Item: Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral

The Issue: The design of the spring clip for the

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

Class II — Potential Health HazardTerminated
April 30, 2012· Stryker Howmedica Osteonics Corp.

Recalled Item: ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah

The Issue: Stryker has updated the instruction for use (IFU)

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

Class II — Potential Health HazardOngoing
April 30, 2012· Stryker Howmedica Osteonics Corp.

Recalled Item: Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate...

The Issue: Stryker has updated the instruction for use (IFU)

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

Class II — Potential Health HazardOngoing
April 29, 2012· Accutron Inc

Recalled Item: Flow Meter

The Issue: Accutron is recalling the Flowmeter (Analgesia Gas Machine)

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

Class I — Serious Health HazardTerminated
April 29, 2012· Accutron Inc

Recalled Item: CM Flowmeter Pkg H

The Issue: Accutron is recalling the Flowmeter (Analgesia Gas Machine)

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

Class I — Serious Health HazardTerminated
April 29, 2012· Accutron Inc

Recalled Item: Newport Portable Package

The Issue: Accutron is recalling the Flowmeter (Analgesia Gas Machine)

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

Class I — Serious Health HazardTerminated
April 29, 2012· Accutron Inc

Recalled Item: Ultra PC% Cabinet Mount Package G

The Issue: Accutron is recalling the Flowmeter (Analgesia Gas Machine)

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

Class I — Serious Health HazardTerminated
April 27, 2012· Intuitive Surgical, Inc.

Recalled Item: Patient Side Cart Battery Box used in conjunction with the

The Issue: Patient Side Cart battery boxes may overheat in

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

Class II — Potential Health HazardTerminated