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 19521–19540 of 38,428 recalls

October 2, 2018· Arrow International Inc

Recalled Item: AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF550x5ML/H 2ML 60LO 6" DUAL CATHS

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF 550 x 5ML/HR 2ML 60LO CPNB

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF w/AS 550 x 0.5-7 ml

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: 0F 550 x 8ML/HR 2ML 60LO CPNB

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF550x5ML/H 2ML 60LO 6" CATH

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF w/AS 550x 0.5 7 ml/hr

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF 550 x 5ML/H FH DL 30hole SAT C

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Arrow International Inc

Recalled Item: AF 550 x 5ML/HR CPNB

The Issue: cracks on the body of the fill

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

Class II — Potential Health HazardTerminated
October 2, 2018· Randox Laboratories Ltd.

Recalled Item: Liquid Cardiac Control

The Issue: Randox has previously issued a recall for Liquid

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

Class II — Potential Health HazardTerminated
October 2, 2018· Pfizer Inc.

Recalled Item: Thermacare HeatWraps Menstrual a) b) Product

The Issue: The firm received complaints of the wrap coming

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

Class II — Potential Health HazardTerminated
October 2, 2018· Pfizer Inc.

Recalled Item: Thermacare Muscle Pain Therapy HeatWraps: a) b) UPC

The Issue: The firm received complaints of the wrap coming

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

Class II — Potential Health HazardTerminated
October 2, 2018· Pfizer Inc.

Recalled Item: Thermacare HEATWRAPS JOINT PAIN THERAPY

The Issue: The firm received complaints of the wrap coming

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail 125 Deg 12x165mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail 130 Deg 10x165mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail Left 130 Deg 11x300mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated
October 2, 2018· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail Left 125 Deg 9x165mm

The Issue: The set screw is not able to advance

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

Class II — Potential Health HazardTerminated