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 4741–4760 of 38,428 recalls

June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Merit Medical Systems, Inc.

Recalled Item: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli

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
June 11, 2024· Canadian Hospital Specialties Ltd.

Recalled Item: Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number:

The Issue: A customer found product with incomplete seals of

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

Class II — Potential Health HazardOngoing
June 11, 2024· Ethicon Sarl, a Johnson & Johnson Company

Recalled Item: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)

The Issue: Some foil pouches were found torn open, impacting

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

Class II — Potential Health HazardOngoing
June 11, 2024· Ethicon Sarl, a Johnson & Johnson Company

Recalled Item: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)

The Issue: Some foil pouches were found torn open, impacting

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

Class II — Potential Health HazardOngoing
June 10, 2024· BioFire Diagnostics, LLC

Recalled Item: BIOFIRE FILMARRAY Pneumonia Panel plus

The Issue: Pneumonia panels have an increased risk of control

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

Class II — Potential Health HazardOngoing
June 10, 2024· BioFire Diagnostics, LLC

Recalled Item: BIOFIRE FILMARRAY Pneumonia Panel

The Issue: Pneumonia panels have an increased risk of control

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

Class II — Potential Health HazardOngoing