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 4581–4600 of 38,428 recalls

June 27, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline convenience kits containing semi-rigid suction liners labeled as...

The Issue: Due to reported adverse events, Medline Industries, LP

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

Class II — Potential Health HazardOngoing
June 27, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline convenience kits containing semi-rigid suction liners labeled as...

The Issue: Due to reported adverse events, Medline Industries, LP

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

Class II — Potential Health HazardOngoing
June 27, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline convenience kits containing semi-rigid suction liners labeled as...

The Issue: Due to reported adverse events, Medline Industries, LP

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

Class II — Potential Health HazardOngoing
June 27, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline convenience kits containing semi-rigid suction liners labeled as...

The Issue: Due to reported adverse events, Medline Industries, LP

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

Class II — Potential Health HazardOngoing
June 27, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline convenience kits containing semi-rigid suction liners labeled as...

The Issue: Due to reported adverse events, Medline Industries, LP

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

Class II — Potential Health HazardOngoing
June 27, 2024· Ventana Medical Systems, Inc.

Recalled Item: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody

The Issue: Their is a potential for high background and

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

Class II — Potential Health HazardOngoing
June 27, 2024· Medivance Inc.

Recalled Item: Arctic Sun Temperature Management Systems

The Issue: If temperature management system fails to reach correct

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

Class II — Potential Health HazardOngoing
June 27, 2024· Boston Scientific Corporation

Recalled Item: Capio SLIM Suture Capturing Device

The Issue: Some lots of Capio SLIM do not consistently

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

Class II — Potential Health HazardOngoing
June 27, 2024· Boston Scientific Corporation

Recalled Item: Capio SLIM Suture Capturing Device

The Issue: Some lots of Capio SLIM do not consistently

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

Class II — Potential Health HazardOngoing
June 27, 2024· LINK BIO CORP

Recalled Item: LINK SymphoKnee Patella Sizing Template

The Issue: The LinkSymphoKnee Patella Sizing Template was incorrectly labeled

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD, Inc.

Recalled Item: smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter

The Issue: The adapter input plug can become damaged or

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: ENT RES 100 ML Non-Sterile W CLAMP

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: ENT RES

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing
June 26, 2024· Smiths Medical ASD Inc.

Recalled Item: CADD Medication Cassette Reservoir

The Issue: Certain CADD Medication Cassette Reservoirs may exhibit a

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

Class II — Potential Health HazardOngoing