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 36481–36500 of 38,428 recalls

December 27, 2012· ConMed Corporation

Recalled Item: ABC(R) NOZZLE

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: UltraClean(R) Accessory Electrode

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: Electrosurgical Tip Cleaner

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: TUR/Endoscopic Cable

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: CONMED(R) ELECTROSURGICAL SAFETY HOLSTER

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 27, 2012· ConMed Corporation

Recalled Item: UltraClean(R) Accessory Electrode 6 inch Coated Blade

The Issue: ConMed received complaints of some devices which had

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

Class II — Potential Health HazardTerminated
December 26, 2012· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation

The Issue: ELS 15 Fr Cannula could potentially contain an

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

Class II — Potential Health HazardTerminated
December 25, 2012· bioMerieux, Inc.

Recalled Item: BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle

The Issue: BacT/ALERT SA Culture Bottle lot 1031866 may contain

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

Class II — Potential Health HazardTerminated
December 21, 2012· NordicNeuroLab AS

Recalled Item: nordicBrainEX Product Usage: nordicBrainEx is an image processing software...

The Issue: There is an error related to the relative

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

Class II — Potential Health HazardTerminated
December 21, 2012· Johnson & Johnson Vision Care, Inc.

Recalled Item: ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

The Issue: Limited number of individual contact lens packages may

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

Class II — Potential Health HazardTerminated
December 21, 2012· Johnson & Johnson Vision Care, Inc.

Recalled Item: 1-DAY ACUVUE MOIST Brand Contact Lenses

The Issue: Limited number of individual contact lens packages may

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

Class II — Potential Health HazardTerminated
December 21, 2012· Integra LifeSciences Corp.

Recalled Item: MAYFIELD¿ Composite Series Base Unit Standard

The Issue: Integra determined there is a possibility that the

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

Class II — Potential Health HazardTerminated
December 21, 2012· Hitachi Chemical Diagnostics Inc

Recalled Item: OPTIGEN Food 30

The Issue: There is no evidence that a visual inspection

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

Class III — Low RiskTerminated
December 20, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended

The Issue: A potential safety risk with the MOSAIQ Oncology

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

Class II — Potential Health HazardTerminated
December 20, 2012· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission

The Issue: Issues have been detected in the Ingenuity TF

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

Class II — Potential Health HazardTerminated
December 20, 2012· Stryker Howmedica Osteonics Corp.

Recalled Item: Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog

The Issue: Reports of handle fracture and subsequent disassociation of

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

Class II — Potential Health HazardTerminated