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 5401–5420 of 38,428 recalls

April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedural kits labeled as: 1) BABY CARE KIT UNIV

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Procedure kits labeled as: 1) CIRCUMCISION SET

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion procedure packs

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedural kits labeled as: 1) SR C SECTION

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion procedure kits

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedure packs containing Shenli syringes

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedure kits labeled as: 1) NEPHROLOGY PACK

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class I — Serious Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion procedure kits labeled as NEURO ANGIO PACK

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class II — Potential Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class I — Serious Health HazardOngoing
April 8, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline procedure kits labeled as: 1) CONTINUOUS BLOCK

The Issue: Medical convenience kits contain plastic syringes affected by

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

Class I — Serious Health HazardOngoing
April 8, 2024· Fresenius Medical Care Holdings, Inc.

Recalled Item: Novalung sensor box is a component of the Novalung Console

The Issue: Issue related to Novalung sensor box, which is

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

Class II — Potential Health HazardOngoing
April 8, 2024· HeartSine Technologies Ltd

Recalled Item: HeartSine samaritan PAD (Public Access Defibrillator)

The Issue: Automated external defibrillators have a manufacturing issue that

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

Class II — Potential Health HazardOngoing
April 8, 2024· Vyaire Medical, Inc.

Recalled Item: Vyaire Medical GmbH

The Issue: of the nozzle separating during patient use

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

Class I — Serious Health HazardOngoing
April 5, 2024· GE Healthcare Finland Oy

Recalled Item: CARESCAPE B650: Model Numbers: a) MBB313

The Issue: GE HealthCare has become aware of the potential

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

Class II — Potential Health HazardOngoing
April 5, 2024· GE Healthcare Finland Oy

Recalled Item: CARESCAPE Canvas 1000

The Issue: GE HealthCare has become aware of the potential

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

Class II — Potential Health HazardOngoing
April 5, 2024· GE Healthcare Finland Oy

Recalled Item: CARESCAPE Canvas Smart Display

The Issue: GE HealthCare has become aware of the potential

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

Class II — Potential Health HazardOngoing
April 5, 2024· GE Healthcare Finland Oy

Recalled Item: CARESCAPE B850 Model Numbers: a) MBC303

The Issue: GE HealthCare has become aware of the potential

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

Class II — Potential Health HazardOngoing
April 5, 2024· GE Healthcare Finland Oy

Recalled Item: CARESCAPE Canvas Smart Display

The Issue: GE HealthCare has become aware of the potential

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

Class II — Potential Health HazardOngoing