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 5961–5980 of 38,428 recalls

February 23, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)

The Issue: Product may have a weak seal which may

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

Class II — Potential Health HazardOngoing
February 23, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE

The Issue: Product may have a weak seal which may

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

Class II — Potential Health HazardOngoing
February 22, 2024· Baxter Healthcare Corporation

Recalled Item: Surgical Tools and Cardiovascular Specialty marketing brochures

The Issue: The Surgical Tools and Cardiovascular Specialty marketing brochures

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

Class II — Potential Health HazardOngoing
February 22, 2024· Baxter Healthcare Corporation

Recalled Item: Surgical Tools and Cardiovascular Specialty marketing brochures

The Issue: The Surgical Tools and Cardiovascular Specialty marketing brochures

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

Class II — Potential Health HazardOngoing
February 22, 2024· Baxter Healthcare Corporation

Recalled Item: Surgical Tools and Cardiovascular Specialty marketing brochures

The Issue: The Surgical Tools and Cardiovascular Specialty marketing brochures

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

Class II — Potential Health HazardOngoing
February 22, 2024· Bolton Medical Inc.

Recalled Item: RELAY PRO Thoracic Stent-Graft System

The Issue: The stent-graft inside the delivery system was the

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

Class II — Potential Health HazardCompleted
February 21, 2024· Abbott Laboratories

Recalled Item: ARCHITECT STAT Myoglobin Reagent Kit

The Issue: The reason for the recall is the failure

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Sinus Compress (French)

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Back Wrap

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Sinus Compress

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Stye Compress

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Alcon Research, LLC

Recalled Item: SYRINGE

The Issue: Medline Bulb irrigation syringes recalled due to potential

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Neck Wrap

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Puritan Medical Products Company, Llc

Recalled Item: HydroFlock Sterile Flocked Collection Device

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: MediBeads Neck Wrap

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Eye Compress

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: MediBeads King Pad

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· Bruder Healthcare Company, LLC

Recalled Item: Thermalon Heating Pad

The Issue: Thermalon and MediBeads moist heat compresses from certain

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

Class II — Potential Health HazardOngoing
February 21, 2024· InfuTronix LLC

Recalled Item: Nimbus Administration Set

The Issue: InfuTronix is removing the Nimbus Infusion Pump Systems

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

Class I — Serious Health HazardOngoing
February 21, 2024· InfuTronix LLC

Recalled Item: Nimbus II Infusion System

The Issue: InfuTronix is removing the Nimbus Infusion Pump Systems

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

Class I — Serious Health HazardOngoing