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 26441–26460 of 38,428 recalls

August 12, 2016· Medtronic Inc., Cardiac Rhythm and Heart Failure

Recalled Item: Medtronic

The Issue: 78 Viva CRT -Ds and Evera ICDs that

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

Class II — Potential Health HazardTerminated
August 12, 2016· Medtronic Inc., Cardiac Rhythm and Heart Failure

Recalled Item: Medtronic

The Issue: 78 Viva CRT -Ds and Evera ICDs that

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

Class II — Potential Health HazardTerminated
August 11, 2016· Synergetics Inc

Recalled Item: 25 gauge VersaVit 2.0 Core Essentials Procedure Pack

The Issue: Vitrectomy cutters have been found not to be

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

Class II — Potential Health HazardTerminated
August 11, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products TRIG Slides

The Issue: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a

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

Class II — Potential Health HazardTerminated
August 11, 2016· Synergetics Inc

Recalled Item: 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator

The Issue: Vitrectomy cutters have been found not to be

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

Class II — Potential Health HazardTerminated
August 11, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products GLU Slides

The Issue: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a

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

Class II — Potential Health HazardTerminated
August 11, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products LAC Slides

The Issue: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a

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

Class II — Potential Health HazardTerminated
August 11, 2016· Synergetics Inc

Recalled Item: 25 gauge VersaVit 2.0 Vitrectomy Cutter

The Issue: Vitrectomy cutters have been found not to be

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

Class II — Potential Health HazardTerminated
August 11, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products URIC Slides

The Issue: Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a

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

Class II — Potential Health HazardTerminated
August 11, 2016· Synergetics Inc

Recalled Item: 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator

The Issue: Vitrectomy cutters have been found not to be

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN):

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN):

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN):

The Issue: There is a potential for the first and/or

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

Class II — Potential Health HazardTerminated
August 11, 2016· DeRoyal Industries Inc

Recalled Item: Geo-Med

The Issue: The firm is recalling two custom surgical kits

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

Class II — Potential Health HazardTerminated
August 11, 2016· DeRoyal Industries Inc

Recalled Item: DeRoyal (R) CYSTO TRAY PGYBK .08

The Issue: The firm is recalling two custom surgical kits

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

Class II — Potential Health HazardTerminated
August 10, 2016· Medline Industries Inc

Recalled Item: Rigid Suction Canister 3000 CC and 2000 CC.

The Issue: Risk of implosion when the Rigid Suction Canister

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

Class II — Potential Health HazardTerminated