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 27181–27200 of 38,428 recalls

April 29, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity CT Model No. 728326

The Issue: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity

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

Class II — Potential Health HazardTerminated
April 29, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance iCT

The Issue: Software issues in versions v4.1 .3/4.1.5 in the

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

Class II — Potential Health HazardTerminated
April 29, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core128 Model No. 728323

The Issue: Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity

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

Class II — Potential Health HazardTerminated
April 29, 2016· Integra LifeSciences Corp.

Recalled Item: Cadence Size 5 Left Tibial Tray Implant

The Issue: As a result of an internal review of

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

Class II — Potential Health HazardTerminated
April 28, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Centaur XPT Immunoassay System

The Issue: The ADVIA Centaur¿ XPT default setting for the

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

Class II — Potential Health HazardTerminated
April 28, 2016· CMP Industries, Llc

Recalled Item: IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
April 28, 2016· CMP Industries, Llc

Recalled Item: IMPAK Liquid Acrylic Resin sold under the following labels: 1)

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
April 28, 2016· Excelsior Medical Corp

Recalled Item: Excelsior Disposable Syringe Heparin Lock Flush

The Issue: Certain lots of Heparin Lock Flush, USP Syringes

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

Class II — Potential Health HazardTerminated
April 28, 2016· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air

The Issue: Due to the buildup of grease within the

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

Class II — Potential Health HazardTerminated
April 28, 2016· Alcon Research, Ltd.

Recalled Item: CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision

The Issue: Alcon is conducting this Voluntary Medical Device Removal

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

Class II — Potential Health HazardTerminated
April 28, 2016· Stryker Sustainability Solutions

Recalled Item: Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
April 27, 2016· Orthofix, Inc

Recalled Item: Firebird NXG Spinal Fixation System Set Screw Driver used to

The Issue: There is a possibility that the subject set

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

Class II — Potential Health HazardTerminated
April 26, 2016· Greiner Bio-One North America, Inc.

Recalled Item: 4 ml FX Sodium Fluoride/Potassium Oxalate tube

The Issue: The 4 ml FX Sodium Fluoride/Potassium Oxalate tube

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

Class II — Potential Health HazardTerminated
April 26, 2016· Greatbatch Medical

Recalled Item: Torque Limiting Screwdriver: Greatbatch Medical

The Issue: Greatbatch Medical has initiated a global Field Recall

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

Class II — Potential Health HazardTerminated
April 26, 2016· Greatbatch Medical

Recalled Item: Torque Limiting Handle: PRECIMED

The Issue: Greatbatch Medical has initiated a global Field Recall

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

Class II — Potential Health HazardTerminated
April 26, 2016· STERILMED, INC.

Recalled Item: Reprocessed Microline Scissor Tips intended to be used with a

The Issue: Sterlilmed is recalling all unexpired Scissor Tips because

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

Class II — Potential Health HazardTerminated
April 26, 2016· Greatbatch Medical

Recalled Item: Torque Limiting Adapter: Torque Limiting Attachment

The Issue: Greatbatch Medical has initiated a global Field Recall

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

Class II — Potential Health HazardTerminated
April 26, 2016· B. Braun Medical, Inc.

Recalled Item: WHIN Infusion Set - 90 Huber Needle and Wing (22

The Issue: for the tip of the Huber needle

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

Class II — Potential Health HazardTerminated
April 25, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba America Medical Systems

The Issue: It has been found that if the scan

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

Class II — Potential Health HazardTerminated
April 25, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba America Medical Systems

The Issue: It has been found that if the scan

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

Class II — Potential Health HazardTerminated