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 17561–17580 of 38,428 recalls

June 10, 2019· Abbott Gmbh & Co. KG

Recalled Item: Alinity ci -series System Control¿Module

The Issue: Abbott has identified an issue with all on

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

Class II — Potential Health HazardTerminated
June 10, 2019· Molded Products Inc

Recalled Item: Luer Lock Set - Catalog # MPC-125

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
June 10, 2019· Santanello Surgical LLC

Recalled Item: VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory

The Issue: Lack of package integrity may compromise sterility

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

Class II — Potential Health HazardTerminated
June 10, 2019· Randox Laboratories, Limited

Recalled Item: Assayed Bovine Multi-Sera Level 1

The Issue: The firm is re-assigning the Mean of all

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

Class III — Low RiskTerminated
June 10, 2019· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView XCT

The Issue: An issue with the handcontroller may result in

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

Class II — Potential Health HazardTerminated
June 10, 2019· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView SPECT

The Issue: An issue with the handcontroller may result in

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

Class II — Potential Health HazardTerminated
June 10, 2019· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView X

The Issue: An issue with the handcontroller may result in

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

Class II — Potential Health HazardTerminated
June 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only)

The Issue: Lack of an adequate sterilization validation

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

Class II — Potential Health HazardTerminated
June 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only)

The Issue: Lack of an adequate sterilization validation

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

Class II — Potential Health HazardTerminated
June 10, 2019· Olympus Corporation of the Americas

Recalled Item: Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm

The Issue: WM-NP/DP2 workstations could become unstable and may fall

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

Class II — Potential Health HazardTerminated
June 7, 2019· Polymer Technology Systems, Inc.

Recalled Item: PTS Panels Lipid Panel test strip: IVD Lipid Panel Test

The Issue: Mislabeling

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

Class III — Low RiskTerminated
June 7, 2019· Polymer Technology Systems, Inc.

Recalled Item: Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel

The Issue: Mislabeling

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

Class III — Low RiskTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Overlap Vest

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Vest

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Frontal Apron with Quick Drop Velcro Closure (no elastic)

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Hood

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Frontal Apron Velcro Closure

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Frontal Support Belt Apron

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: 2 pc Full Overlap Vest & Kilt

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated
June 7, 2019· Burlington Medical, LLC

Recalled Item: Front/Back Apron with Stretch Velcro Closure

The Issue: The protective material used in the manufacture of

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

Class II — Potential Health HazardTerminated