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 1121–1140 of 38,428 recalls

September 18, 2025· Cardinal Health 200, LLC

Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump

The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)

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

Class II — Potential Health HazardOngoing
September 18, 2025· Cardinal Health 200, LLC

Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump"

The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)

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

Class II — Potential Health HazardOngoing
September 18, 2025· Cardinal Health 200, LLC

Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump"

The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)

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

Class II — Potential Health HazardOngoing
September 18, 2025· Cardinal Health 200, LLC

Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump"

The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)

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

Class II — Potential Health HazardOngoing
September 18, 2025· HeartSine Technologies Ltd

Recalled Item: HeartSine Pad-Pak

The Issue: Due to customer complaints, defibrillator pads may contain

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

Class II — Potential Health HazardOngoing
September 18, 2025· Cardinal Health 200, LLC

Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump"

The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)

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

Class II — Potential Health HazardOngoing
September 18, 2025· GE Medical Systems, LLC

Recalled Item: LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7.

The Issue: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may

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

Class II — Potential Health HazardOngoing
September 18, 2025· GE Medical Systems, LLC

Recalled Item: LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7.

The Issue: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may

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

Class II — Potential Health HazardOngoing
September 18, 2025· Cook Medical Incorporated

Recalled Item: Zenith Alpha 2 Thoracic Endovascular Graft

The Issue: Affected devices may contain PTFE coating scrapings. Scrapings

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

Class I — Serious Health HazardOngoing
September 18, 2025· Fisher & Paykel Healthcare, Ltd.

Recalled Item: Airvo 2

The Issue: When unintentionally disconnected from power source, humidifier device

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

Class II — Potential Health HazardOngoing
September 18, 2025· GE Medical Systems, LLC

Recalled Item: LOGIQ P10 series with software version R4.5.7 Model Number 5877534

The Issue: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga.

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: Combined Spinal and Epidural Anesthesia Tray 2

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: Combined Spinal and Epidural Anesthesia Tray

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga.

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: ESPOCAN Combined Spinal and Epidural Anesthesia Tray

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga.

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: Design Options

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing
September 18, 2025· B BRAUN MEDICAL INC

Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray

The Issue: for the lid of the catheter connector

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

Class II — Potential Health HazardOngoing