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 20821–20840 of 38,428 recalls

May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 24, 2018· Sun Med, LLC

Recalled Item: STAT-Check MANUAL RESUSCITATOR / VENTILATOR

The Issue: There is a potential for the patient port

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

Class II — Potential Health HazardTerminated
May 23, 2018· Helena Laboratories, Corp.

Recalled Item: Collagen Reagent

The Issue: Through an investigation, it has been determined that

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

Class III — Low RiskOngoing
May 23, 2018· Helena Laboratories, Corp.

Recalled Item: Platelet Aggregation Kit

The Issue: Through an investigation, it has been determined that

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

Class III — Low RiskOngoing
May 23, 2018· Ortho Kinematics, Inc

Recalled Item: Vertebral Motion Analyzer (VMA)

The Issue: This email is to provide notification that, due

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

Class II — Potential Health HazardOngoing
May 23, 2018· Arrow International Inc

Recalled Item: Percutaneous Sheath Introducer Kit for use with 7 - 7.5

The Issue: Product contains dry natural rubber latex. Label states

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

Class II — Potential Health HazardTerminated
May 23, 2018· Steris Corporation

Recalled Item: Reliance 1227 Cart and Utensil Washer/Disinfector

The Issue: The firm has become aware that the Reliance

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

Class II — Potential Health HazardTerminated
May 22, 2018· COVIDIEN MEDTRONIC

Recalled Item: Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardOngoing
May 22, 2018· COVIDIEN MEDTRONIC

Recalled Item: Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardOngoing
May 22, 2018· COVIDIEN MEDTRONIC

Recalled Item: Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardOngoing
May 22, 2018· NewDeal SA

Recalled Item: TIBIAXYS

The Issue: Use of the impacted product may cause a

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

Class II — Potential Health HazardTerminated