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 35521–35540 of 38,428 recalls

June 7, 2013· Baxter Healthcare Corp.

Recalled Item: SV Elastomeric Infusion Device. Indicated for the intravenous

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Multirate Infusor Devices. Indicated for the intravenous administration

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Infusor SV and LV Elastomeric Infusion Devices. Indicated

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Multiday lnfusor

The Issue: Due to an increase in complaints for leaks

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Basal/Bolus Infusor. Indicated for the intravenous administration of

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 6, 2013· Carestream Health, Inc.

Recalled Item: Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

The Issue: Carestream Health Inc. is recalling the power plug

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

Class II — Potential Health HazardTerminated
June 6, 2013· Sybron Dental Specialties

Recalled Item: AOA Mini RPE Screw Assembly

The Issue: The firm initiated the recall of AOA Mini

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

Class II — Potential Health HazardTerminated
June 6, 2013· Endogastric Solutions Inc

Recalled Item: EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories....

The Issue: Endogastric Solutions, Inc. has received a limited number

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

Class II — Potential Health HazardTerminated
June 6, 2013· Ortho-Clinical Diagnostics

Recalled Item: Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375

The Issue: Ortho Clinical Diagnostics is recalling CM/RT wear pads

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL Vancomycin Screen Agar

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL Schaedler K-V Agar with 5% Sheep Blood

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL Anaerobe CNA Agar with 5% Sheep Blood //

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL BCYE Selective Agar with PAV

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV)

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium)

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 6, 2013· Becton Dickinson & Co.

Recalled Item: BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV)

The Issue: Microbiological identification media may exhibit reduced levels of

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

Class II — Potential Health HazardTerminated
June 5, 2013· Toby Orthopaedics, Inc.

Recalled Item: PANTERA Proximal Humerus Fracture Plate System

The Issue: suture clip breaking during a humerus fixation

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

Class II — Potential Health HazardTerminated
June 5, 2013· 3M Company - Health Care Business

Recalled Item: 3M ESPE

The Issue: 3M is recalling specific lots of 3M ESPE

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

Class III — Low RiskTerminated
June 5, 2013· Fisher Scientific Co

Recalled Item: Fisherbrand Sterile Swab

The Issue: The firm is recalling Fisherbrand Sterile Swabs due

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

Class II — Potential Health HazardTerminated