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 26921–26940 of 38,428 recalls

June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-000VF

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: Spike Set

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T100-000F

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T095-022

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· WalkMed Infusion, LLC

Recalled Item: T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site.

The Issue: WalkMed Infusion, LLC Announces a Voluntary Field Action

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

Class II — Potential Health HazardTerminated
June 14, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Big Bore Radiology tomography X-ray system scanner

The Issue: Socket Head Cap Screws (SHCS) used in the

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

Class II — Potential Health HazardTerminated
June 14, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Big Bore Oncology tomography X-ray system scanner

The Issue: Socket Head Cap Screws (SHCS) used in the

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

Class II — Potential Health HazardTerminated
June 13, 2016· Biomet Microfixation, LLC

Recalled Item: Hard Tissue Replacement (HTR) Implant

The Issue: sterility deficiency

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

Class II — Potential Health HazardTerminated
June 13, 2016· Richard-Allan Scientific Company

Recalled Item: Richard Allan Scientific 10% Neutral Buffered Formalin

The Issue: contamination with potassium hydroxide may have an

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

Class II — Potential Health HazardTerminated
June 13, 2016· Cardiovascular Systems Inc

Recalled Item: ViperWire Advance Peripheral Guide Wire

The Issue: The pouch label was missing the use by

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

Class II — Potential Health HazardTerminated
June 10, 2016· Medtronic Neuromodulation

Recalled Item: Medtronic

The Issue: Medtronic has voluntarily decided to retrieve unused Model

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

Class II — Potential Health HazardTerminated
June 10, 2016· Biomet, Inc.

Recalled Item: TSP Hip Fracture Plating System device

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 10, 2016· Dako North America Inc.

Recalled Item: Dako HER2 CISH pharmDx Kit

The Issue: An incorrect HER2 probe concentration was used when

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

Class II — Potential Health HazardTerminated
June 9, 2016· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy

The Issue: If an exposure is aborted during a stereo

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

Class II — Potential Health HazardTerminated
June 9, 2016· Bayer Healthcare

Recalled Item: Angiographic Injector and Syringe

The Issue: Bayer Healthcare is initiating this recall due to

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

Class II — Potential Health HazardTerminated