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 8501–8520 of 38,428 recalls

March 24, 2023· Cordis US Corp

Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System

The Issue: There is a potential for separation of the

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

Class I — Serious Health HazardOngoing
March 24, 2023· Cordis US Corp

Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System

The Issue: There is a potential for separation of the

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

Class I — Serious Health HazardOngoing
March 24, 2023· Cordis US Corp

Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System

The Issue: There is a potential for separation of the

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

Class I — Serious Health HazardOngoing
March 24, 2023· Cordis US Corp

Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System

The Issue: There is a potential for separation of the

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

Class I — Serious Health HazardOngoing
March 24, 2023· Cordis US Corp

Recalled Item: ANGIOGUARD RX / XP Emboli Capture Guidewire System

The Issue: There is a potential for separation of the

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

Class I — Serious Health HazardOngoing
March 24, 2023· Richard Wolf GmbH

Recalled Item: FLEX. BIOPSY FORCEPS 5FR WL 550MM

The Issue: Potentially unable to open forceps jaws when the

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

Class II — Potential Health HazardOngoing
March 24, 2023· Richard Wolf GmbH

Recalled Item: FLEX. GRASP. FORCEPS 5FR WL 550MM

The Issue: Potentially unable to open forceps jaws when the

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

Class II — Potential Health HazardOngoing
March 24, 2023· Richard Wolf GmbH

Recalled Item: FLEX. GRASP. FORCEPS 6.6FR WL 550MM

The Issue: Potentially unable to open forceps jaws when the

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

Class II — Potential Health HazardOngoing
March 24, 2023· Richard Wolf GmbH

Recalled Item: FLEX. GRASP. FORCEPS 5FR WL 550MM

The Issue: Potentially unable to open forceps jaws when the

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

Class II — Potential Health HazardOngoing
March 24, 2023· Covidien

Recalled Item: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff

The Issue: A manufacturing error, resulted in a less than

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

Class I — Serious Health HazardOngoing
March 23, 2023· ASO LLC

Recalled Item: WALGREENS BANDAGES

The Issue: The adhesive bandage contains 0.1% benzalkonium chloride impregnated

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

Class II — Potential Health HazardOngoing
March 22, 2023· ICU Medical Inc

Recalled Item: Replacement Battery List Number SUB0000864

The Issue: Due to a manufacturing defect from the battery

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

Class I — Serious Health HazardOngoing
March 22, 2023· ICU Medical Inc

Recalled Item: ASM Replacement Battery

The Issue: Due to a manufacturing defect from the battery

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

Class I — Serious Health HazardOngoing
March 22, 2023· ICU Medical Inc

Recalled Item: ASM Replacement Battery

The Issue: Due to a manufacturing defect from the battery

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

Class I — Serious Health HazardOngoing
March 22, 2023· ICU Medical Inc

Recalled Item: Replacement Battery List Number SUB0000594 found in Plum A+ &

The Issue: Due to a manufacturing defect from the battery

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

Class I — Serious Health HazardOngoing
March 22, 2023· Diagnostica Stago, Inc.

Recalled Item: STA Compact Automated Multi-Parametric Analyzer

The Issue: An internal investigation identified a bug in this

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

Class II — Potential Health HazardOngoing
March 22, 2023· Diagnostica Stago, Inc.

Recalled Item: STA Compact Max fully automatic clinical analyzer

The Issue: An internal investigation identified a bug in this

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

Class II — Potential Health HazardOngoing
March 22, 2023· Diagnostica Stago, Inc.

Recalled Item: STA R Max fully automatic clinical instrument designed to perform

The Issue: An internal investigation identified a bug in this

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

Class II — Potential Health HazardOngoing
March 22, 2023· ROi CPS LLC

Recalled Item: Sterile surgical convenience kit: regard Item Number 800706005

The Issue: The recalling firm was notified by their supplier

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

Class II — Potential Health HazardOngoing
March 22, 2023· ROi CPS LLC

Recalled Item: Sterile surgical convenience kit: regard Item Number: 800753005

The Issue: The recalling firm was notified by their supplier

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

Class II — Potential Health HazardOngoing