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 25361–25380 of 38,428 recalls

January 1, 2017· Standex Intl Corp

Recalled Item: Standex International Bakers Pride Microwave Ovens Model E300

The Issue: It was discovered that all five microwave ovens

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

Class II — Potential Health HazardTerminated
January 1, 2017· BioMerieux SA

Recalled Item: Ceftriaxone TX 32 US S30

The Issue: performance issue on strain categorization

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

Class II — Potential Health HazardTerminated
December 30, 2016· Hospira Inc., A Pfizer Company

Recalled Item: Plum 360 Infusion Pump

The Issue: Depleted Battery alarm shows instead of Replace Battery

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

Class II — Potential Health HazardTerminated
December 29, 2016· Synthes (USA) Products LLC

Recalled Item: Synthes Radial Head Prosthesis System

The Issue: There is the possibility that the radial stem

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

Class II — Potential Health HazardTerminated
December 28, 2016· American Contract Systems, Inc.

Recalled Item: Powdered Surgical Gloves

The Issue: Powdered Surgical Gloves are an FDA banned substance

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-115: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-112BT: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-115BT: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 900-115: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-110: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-120BT: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 900-112: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 900-120: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 900-130: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-120: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 28, 2016· Medtronic Advanced Energy, LLC

Recalled Item: Intact Disposable Wands (part of the Intact System) 777-112: 5

The Issue: Product sterility compromised due to breach of sterile

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

Class II — Potential Health HazardTerminated
December 27, 2016· Villa Sistemi Medicali S.P.A.

Recalled Item: Juno DRF

The Issue: Patient fell from the table because the footrest

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

Class II — Potential Health HazardTerminated
December 27, 2016· Villa Sistemi Medicali S.P.A.

Recalled Item: Apollo

The Issue: Patient fell from the table because the footrest

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

Class II — Potential Health HazardTerminated
December 27, 2016· Villa Sistemi Medicali S.P.A.

Recalled Item: Apollo DRF

The Issue: Patient fell from the table because the footrest

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

Class II — Potential Health HazardTerminated
December 27, 2016· Villa Sistemi Medicali S.P.A.

Recalled Item: Apollo EZ

The Issue: Patient fell from the table because the footrest

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

Class II — Potential Health HazardTerminated