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 24701–24720 of 38,428 recalls

March 9, 2017· Smith & Nephew, Inc.

Recalled Item: D-RAD

The Issue: The expiration dates on the labeling are incorrect,

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

Class II — Potential Health HazardTerminated
March 9, 2017· Smith & Nephew, Inc.

Recalled Item: D-RAD

The Issue: The expiration dates on the labeling are incorrect,

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

Class II — Potential Health HazardTerminated
March 9, 2017· Cincinnati Sub-Zero Products Inc

Recalled Item: Hemotherm CE

The Issue: Improperly rated fuses were used in the manufacture

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

Class II — Potential Health HazardTerminated
March 9, 2017· C.R. Bard, Inc.

Recalled Item: SURESTEP Tray

The Issue: Misbranded: Product labeled, Not made with natural rubber

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

Class II — Potential Health HazardCompleted
March 9, 2017· Keystone Dental Inc

Recalled Item: Keystone Dental Inc. PrimaConnex Straight Implant TC

The Issue: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: EYE KIT The Covidien Curity Oval Eye Pads are individually

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Centurion Medical Products Corporation

Recalled Item: OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are

The Issue: Centurion Medical Products is recalling Convenience Kits that

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

Class II — Potential Health HazardTerminated
March 9, 2017· Ion Beam Applications S.A.

Recalled Item: Proteus 235

The Issue: The Proton Therapy System can allow gantry rotation

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

Class II — Potential Health HazardTerminated
March 8, 2017· Biomet 3i, LLC

Recalled Item: BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic

The Issue: A single lot of product that potentially has

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

Class II — Potential Health HazardTerminated
March 8, 2017· Ortho-Clinical Diagnostics

Recalled Item: enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software...

The Issue: Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinic

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

Class II — Potential Health HazardTerminated
March 8, 2017· Sonesta Medical Ab

Recalled Item: Sonesta S2

The Issue: The user / service manual for the Sonesta

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

Class II — Potential Health HazardTerminated
March 8, 2017· Ferno-Washington Inc

Recalled Item: Ferno PROFlexx¿ Model 28Z Chair Cot

The Issue: The recall was initiated as a result of

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

Class II — Potential Health HazardTerminated
March 8, 2017· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur BR assay Cat No. 03896216

The Issue: for the ADVIA Centaur Syphilis assay to

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

Class II — Potential Health HazardTerminated
March 8, 2017· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur BR assay Cat No. 02419937

The Issue: for the ADVIA Centaur Syphilis assay to

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

Class II — Potential Health HazardTerminated
March 8, 2017· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur BR assay Cat No. 09010686

The Issue: for the ADVIA Centaur Syphilis assay to

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

Class II — Potential Health HazardTerminated