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 35881–35900 of 38,428 recalls

April 11, 2013· mobility unlimited inc

Recalled Item: KayserBetten model IDA beds Product Usage: BED

The Issue: Some joints on the doors of a limited

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

Class II — Potential Health HazardTerminated
April 11, 2013· Varian Medical Systems, Inc.

Recalled Item: Segmented Cylinder Applicator Set

The Issue: Segmented cylinder applicator set may slip during treatment,

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

Class II — Potential Health HazardTerminated
April 10, 2013· Philips Medical Systems, Inc.

Recalled Item: Philips HeartStart MRx Monitor/Defibrillator Models: M3536A

The Issue: Device Operating on Battery Power May Shutdown without

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

Class II — Potential Health HazardTerminated
April 10, 2013· GE Healthcare, LLC

Recalled Item: The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT

The Issue: GE Healthcare has recently become aware of an

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

Class II — Potential Health HazardTerminated
April 10, 2013· Boston Scientific CRM Corp

Recalled Item: LATITUDE¿ Patient Management System

The Issue: Boston Scientific CRM is conducting a recall on

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

Class II — Potential Health HazardTerminated
April 10, 2013· Symmetry Medical/SSI

Recalled Item: Codman(R) Collins Radioparent Sternal Blade Nylon

The Issue: There is a possibility that the Collins Radioparent

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

Class II — Potential Health HazardTerminated
April 9, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs

The Issue: Cartridges may contain individual discs which were not

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

Class II — Potential Health HazardTerminated
April 9, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs

The Issue: Cartridges may contain individual discs which were not

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

Class II — Potential Health HazardTerminated
April 9, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs

The Issue: Cartridges may contain individual discs which were not

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

Class II — Potential Health HazardTerminated
April 9, 2013· Remel Inc

Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs

The Issue: Cartridges may contain individual discs which were not

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

Class II — Potential Health HazardTerminated
April 9, 2013· Ebi, Llc

Recalled Item: Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an

The Issue: Several complaints were recorded regarding one of the

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

Class II — Potential Health HazardTerminated
April 9, 2013· GE Healthcare, LLC

Recalled Item: GE 1.5T Signa HDxt

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
April 9, 2013· National Biological Corp

Recalled Item: Dermalight 80 Model Number UVB-080

The Issue: The incorrect manual may have been packaged with

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

Class III — Low RiskTerminated
April 9, 2013· Instrumentation Laboratory Co.

Recalled Item: HemosIL RecombiPlasTin 2G

The Issue: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G),

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

Class II — Potential Health HazardTerminated
April 9, 2013· Alpine Biomed Aps

Recalled Item: Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103

The Issue: Alpine Biomed ApS is recalling Natus neurology Dantec

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

Class II — Potential Health HazardTerminated
April 8, 2013· Ethicon Endo-Surgery Inc

Recalled Item: Endopath Electrosurgery Probe Plus II

The Issue: The firm is recalling the ENDOPATH Probe Plus

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

Class II — Potential Health HazardTerminated
April 8, 2013· National Biological Corp

Recalled Item: Dermalight 80 Model Number UVB-083

The Issue: The incorrect manual may have been packaged with

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

Class III — Low RiskTerminated
April 8, 2013· Covidien LLC

Recalled Item: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode...

The Issue: Defibrillation Electrodes may arc/spark result in thermal damage

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

Class II — Potential Health HazardTerminated
April 8, 2013· Philips Healthcare Inc.

Recalled Item: HeartStart MRx Monitor/Defribillator

The Issue: Device may fail to deliver defibrillation therapy in

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

Class II — Potential Health HazardTerminated
April 8, 2013· Covidien LLC

Recalled Item: Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product...

The Issue: Defibrillation Electrodes may arc/spark result in thermal damage

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

Class II — Potential Health HazardTerminated