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 6301–6320 of 38,428 recalls

December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: The listed lots of Cardinal Health Monoject Enteral

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: The listed lots of Cardinal Health Monoject Enteral

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

Class I — Serious Health HazardOngoing
December 28, 2023· Maquet Medical Systems USA

Recalled Item: Bubble Sensor (.5720)

The Issue: The Bubble Sensor optional accessory to the CARDIOHELP-i

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

Class II — Potential Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: The listed lots of Cardinal Health Monoject Enteral

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: The listed lots of Cardinal Health Monoject Enteral

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 28, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Monoject

The Issue: Cardinal Health is expanding their previous product correction

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

Class I — Serious Health HazardOngoing
December 27, 2023· TruAbutment Inc.

Recalled Item: TruScan Body

The Issue: Retroactive: Due to defect and quality issues dental

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

Class II — Potential Health HazardOngoing
December 27, 2023· Abiomed, Inc.

Recalled Item: Impella catheters - Intravascular micro axial blood pumps that support

The Issue: New warnings are being added to the Instructions

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

Class II — Potential Health HazardOngoing
December 27, 2023· Abiomed, Inc.

Recalled Item: Impella catheters - Intravascular micro axial blood pumps that support

The Issue: IFU has been updated to include warnings about

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

Class I — Serious Health HazardOngoing
December 26, 2023· Wipro GE Healthcare Private Ltd.

Recalled Item: GE Healthcare neonatal incubator

The Issue: GE HealthCare has become aware that the bedside

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

Class I — Serious Health HazardOngoing
December 26, 2023· Wipro GE Healthcare Private Ltd.

Recalled Item: GE Healthcare Care Plus Hood Door FRU kit

The Issue: GE HealthCare has become aware that the bedside

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

Class I — Serious Health HazardOngoing
December 26, 2023· Wipro GE Healthcare Private Ltd.

Recalled Item: GE Healthcare Lullaby Incubator Model Hood Door FRU kit

The Issue: GE HealthCare has become aware that the bedside

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

Class I — Serious Health HazardOngoing