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 2421–2440 of 38,428 recalls

March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare Carestation 620 A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 650 A2

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 650C A2

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare Carestation 620 SE

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 750c A2

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 650 A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare Carestation 650 A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 750 A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 620 A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare CARESTATION 750c A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· GE Medical Systems China Co., Ltd.

Recalled Item: GE Healthcare Carestation 650c A1

The Issue: GE HealthCare has become aware that certain Carestation

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

Class I — Serious Health HazardOngoing
March 21, 2025· Radiometer Medical ApS

Recalled Item: Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090

The Issue: ABL90 FLEX and ABL90 FLEX PLUS analyzers running

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Connex Vital Signs Monitor

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Welch Allyn Connex Spot Monitor

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as:

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Spot Vital Signs 4400 Device

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Green Series 777 Wall System

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 21, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn Connex Integrated Wall System

The Issue: Undeclared Natural

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

Class II — Potential Health HazardOngoing
March 20, 2025· Beckman Coulter Inc.

Recalled Item: DxC 500 AU Clinical Chemistry Analyzer

The Issue: Beckman Coulter is recalling their DxC 500 AU

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

Class II — Potential Health HazardOngoing