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 36081–36100 of 38,428 recalls

March 13, 2013· Separation Technology, Inc.

Recalled Item: SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells

The Issue: Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges

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

Class II — Potential Health HazardTerminated
March 13, 2013· Masimo Corporation

Recalled Item: Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and

The Issue: Masimo has identified a very small number (0.02%)

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

Class II — Potential Health HazardTerminated
March 13, 2013· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur Vitamin D Assay (100 tests)

The Issue: Negative bias in patient samples for Vitamin D

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

Class II — Potential Health HazardTerminated
March 13, 2013· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur Vitamin D Assay (500 tests)

The Issue: Negative bias in patient samples for Vitamin D

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

Class II — Potential Health HazardTerminated
March 13, 2013· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur Vitamin D Calibrator 2-pack

The Issue: Negative bias in patient samples for Vitamin D

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

Class II — Potential Health HazardTerminated
March 13, 2013· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur Vitamin D Calibrator 6-pack

The Issue: Negative bias in patient samples for Vitamin D

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

Class II — Potential Health HazardTerminated
March 13, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm)

The Issue: Medtronic has identified an issue with a specific

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

Class II — Potential Health HazardTerminated
March 13, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire

The Issue: Medtronic has identified an issue involving specific lot

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

Class II — Potential Health HazardTerminated
March 12, 2013· Bio-Detek, Inc.

Recalled Item: Medsolutions4U Multi-Function Electrodes to be used with PhysioControl...

The Issue: Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect

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

Class II — Potential Health HazardTerminated
March 12, 2013· GE Healthcare It

Recalled Item: The Centricity Laboratory System is intended to be an information

The Issue: GE Healthcare is aware of a potential safety

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

Class II — Potential Health HazardTerminated
March 12, 2013· Custom Ultrasonics, Inc.

Recalled Item: Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

The Issue: Certain System 83 Plus 2 and System 83

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

Class II — Potential Health HazardTerminated
March 12, 2013· GE Healthcare It

Recalled Item: The Centricity Laboratory System is intended to be an information

The Issue: GE Healthcare has become aware of a potential

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

Class II — Potential Health HazardTerminated
March 12, 2013· Berchtold Corp.

Recalled Item: Hand Controls for Operon D750

The Issue: The firm received complaints for unintended movements

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

Class II — Potential Health HazardTerminated
March 12, 2013· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT 16-Slice Water

The Issue: Philips Healthcare received a report from the field

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

Class II — Potential Health HazardTerminated
March 11, 2013· GE Healthcare It

Recalled Item: Centricity Perinatal and Centricity Intensive Care is intended to be

The Issue: 1) Under rare network conditions, a Centricity Perinatal

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

Class II — Potential Health HazardTerminated
March 11, 2013· Becton Dickinson & Co.

Recalled Item: BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used

The Issue: Microbiological media may be contaminated with bacteria

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

Class II — Potential Health HazardTerminated
March 11, 2013· Becton Dickinson & Co.

Recalled Item: BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and

The Issue: Microbiological media may be contaminated with bacteria

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

Class II — Potential Health HazardTerminated
March 11, 2013· Becton Dickinson & Co.

Recalled Item: BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.

The Issue: Microbiological media may be contaminated with bacteria

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

Class II — Potential Health HazardTerminated
March 11, 2013· Lifescan Inc

Recalled Item: All OneTouch Verio IQ Blood Glucose Meters sold as: Verio

The Issue: The Verio IQ meter will shut off and

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

Class I — Serious Health HazardTerminated
March 11, 2013· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the

The Issue: Siemens has observed that the listed lot numbers

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

Class II — Potential Health HazardTerminated