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 36321–36340 of 38,428 recalls

February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+ Hyperbaric Infusion System is a cassette based

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+3 Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+3 Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+ Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+3 Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+ Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+ Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Hospira Inc.

Recalled Item: The Plum A+ Infusion System is a cassette based multifunction

The Issue: Plum A+ infusers have the potential for the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Integra LifeSciences Corp.

Recalled Item: Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and

The Issue: The firm has received numerous complaints of the

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

Class II — Potential Health HazardTerminated
February 1, 2013· Exactech, Inc.

Recalled Item: Optetrak Logic Comprehensive Knee Prosthesis System

The Issue: A dimensional mismatch was identified which can potentially

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

Class II — Potential Health HazardTerminated
February 1, 2013· Orthofix, Inc

Recalled Item: Firebird Spinal Fixation System

The Issue: There is a possibility that the Set Screw

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

Class II — Potential Health HazardTerminated
February 1, 2013· Greiner Bio-One North America, Inc.

Recalled Item: VACUETTE Safety Blood Collection Set + Luer Adapter

The Issue: The VACUETTE Safety Blood Collection Set + Luer

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

Class II — Potential Health HazardTerminated
January 31, 2013· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus

The Issue: During the course of product monitoring, Siemens became

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

Class II — Potential Health HazardTerminated
January 31, 2013· Hitachi Medical Systems America Inc

Recalled Item: Echelon

The Issue: Hitachi discovered a software error that can occur

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

Class II — Potential Health HazardTerminated
January 31, 2013· Salyer Prn Biomedical

Recalled Item: Century Console Base

The Issue: Concerns that the addition of the UPS Battery

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

Class II — Potential Health HazardTerminated
January 31, 2013· Medtronic Navigation, Inc.

Recalled Item: Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic...

The Issue: failure of the braking system that controls

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

Class II — Potential Health HazardTerminated
January 30, 2013· QIAGEN Gaithersburg, Inc.

Recalled Item: QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)

The Issue: CMV RG PCR kits may contain a mixture

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

Class II — Potential Health HazardTerminated
January 30, 2013· QIAGEN Gaithersburg, Inc.

Recalled Item: QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)

The Issue: CMV RG PCR kits may contain a mixture

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

Class II — Potential Health HazardTerminated
January 30, 2013· Edwards Lifesciences, LLC

Recalled Item: Pressure Monitoring sets with VAMP Plus closed blood sampling system

The Issue: The device is being recalled because the firm

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

Class II — Potential Health HazardTerminated
January 29, 2013· Vascular Solutions, Inc.

Recalled Item: Vascular Solutions

The Issue: Vascular Solutions, Inc has discovered a potential problem

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

Class II — Potential Health HazardTerminated