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 16281–16300 of 38,428 recalls

November 24, 2019· Microvention, Inc.

Recalled Item: Terumo AZUR Peripheral Coil System

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Zest Anchors LLC

Recalled Item: LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

The Issue: The abutment provided with the Implant System may

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

Class II — Potential Health HazardOngoing
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo HydroSoft 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 18

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 18

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo HydroFrame 18

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo HydroFrame 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 18

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo HydroSoft 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 18

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Microvention, Inc.

Recalled Item: MicroVention Terumo Microplex 10

The Issue: The devices may be missing the implant coil

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

Class II — Potential Health HazardTerminated
November 22, 2019· Elekta Inc

Recalled Item: Monaco Radiation Treatment Planning System (RTP) System

The Issue: Monaco is using the incorrect energy when optimizing

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

Class II — Potential Health HazardOngoing
November 21, 2019· Radiometer Medical ApS

Recalled Item: ABL90 FLEX

The Issue: The analyzers fail on S7950 (Range +) QC

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

Class II — Potential Health HazardTerminated