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 8061–8080 of 38,428 recalls

May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE NON-STERILE PVP SOLUTION

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
May 18, 2023· Baxter Healthcare Corporation

Recalled Item: Allen Advance Chest Support with Pad

The Issue: for the device to crack where the

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE NON-STERILE PVP SOLUTION

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE NON-STERILE PVP SOLUTION

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE NON-STERILE PVP SOLUTION

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE NON-STERILE PVP SOLUTION

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX -i Neonatal

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Small Adult

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Pediatric

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: BEQ-HMO 50000-USA/ QUADROX-i Small

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX -i Neonatal

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Adult

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-iD Adult

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-iD Pediatric

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: BEQ-HMOD70000-USA/QUADROX-iD

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-iR

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Adult

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Pediatric

The Issue: Product packaging may exhibit small pinholes which may

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: QUADROX-i Small Adult

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing
May 18, 2023· Maquet Medical Systems USA

Recalled Item: Venous Hardshell Cardiotomy Reservoir

The Issue: 1. An accessory may be improperly placed during

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

Class II — Potential Health HazardOngoing