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 1221–1240 of 38,428 recalls

September 11, 2025· Boston Scientific Corporation

Recalled Item: LGX Preconnect with TENACIO Pump with InhibiZone

The Issue: The potential for devices to experience inflation and/or

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

Class II — Potential Health HazardOngoing
September 11, 2025· Olympus Corporation of the Americas

Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

The Issue: Additional IFU updates to provide further clarification on

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

Class I — Serious Health HazardOngoing
September 11, 2025· Olympus Corporation of the Americas

Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

The Issue: Additional IFU updates to provide further clarification on

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

Class I — Serious Health HazardOngoing
September 11, 2025· Boston Scientific Corporation

Recalled Item: CX Preconnect with TENACIO Pump with InhibiZone

The Issue: The potential for devices to experience inflation and/or

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

Class II — Potential Health HazardOngoing
September 11, 2025· Olympus Corporation of the Americas

Recalled Item: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

The Issue: Additional IFU updates to provide further clarification on

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

Class I — Serious Health HazardOngoing
September 11, 2025· Olympus Corporation of the Americas

Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

The Issue: Additional IFU updates to provide further clarification on

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

Class I — Serious Health HazardOngoing
September 11, 2025· CareFusion 303, Inc.

Recalled Item: BD Alaris Pump Infusion Sets for the following numbers: C24101E

The Issue: Infusion pump module used with compatible pump infusion

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

Class I — Serious Health HazardOngoing
September 10, 2025· Abbott

Recalled Item: TactiFlex Sensor Enabled Ablation Catheter

The Issue: Abbott has become aware of a limited number

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

Class I — Serious Health HazardOngoing
September 10, 2025· Abbott

Recalled Item: TactiFlex Sensor Enabled Ablation Catheter

The Issue: Abbott has become aware of a limited number

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

Class I — Serious Health HazardOngoing
September 10, 2025· Abbott

Recalled Item: TactiFlex Sensor Enabled Ablation Catheter

The Issue: Abbott has become aware of a limited number

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

Class I — Serious Health HazardOngoing
September 10, 2025· Abbott

Recalled Item: TactiFlex Sensor Enabled Ablation Catheter

The Issue: Abbott has become aware of a limited number

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

Class I — Serious Health HazardOngoing
September 10, 2025· Medline Industries, LP

Recalled Item: Medline Adult Anesthesia Set

The Issue: Specific items and lots of Medline Kits may

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

Class II — Potential Health HazardOngoing
September 10, 2025· Abbott

Recalled Item: TactiFlex Sensor Enabled Ablation Catheter

The Issue: Abbott has become aware of a limited number

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

Class I — Serious Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Femoral Head (Metal 22

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Endo Head (Metal uni-polar

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· BioPro, Inc.

Recalled Item: BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD

The Issue: packaging issue that could compromise the sterile

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

Class II — Potential Health HazardOngoing
September 9, 2025· NOXBOX LTD

Recalled Item: NOxBOXi Nitric Oxide Delivery System

The Issue: Fluctuations may be more likely to occur if

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

Class I — Serious Health HazardOngoing