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 1661–1680 of 38,428 recalls

July 11, 2025· Flexicare Medical (Dongguan) Ltd.

Recalled Item: BritePro Solo Mini with Pro Miller Blade Size 1.5

The Issue: Laryngoscope handles may not illuminate as intended

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

Class I — Serious Health HazardOngoing
July 11, 2025· Flexicare Medical (Dongguan) Ltd.

Recalled Item: BritePro Solo Single-Use Fiber Optic Laryngoscope Handle :040-310AU and 040-310U

The Issue: Laryngoscope handles may not illuminate as intended

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

Class I — Serious Health HazardOngoing
July 11, 2025· Flexicare Medical (Dongguan) Ltd.

Recalled Item: Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle

The Issue: Laryngoscope handles may not illuminate as intended

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

Class I — Serious Health HazardOngoing
July 11, 2025· Flexicare Medical (Dongguan) Ltd.

Recalled Item: BritePro Solo Single-Use Fiber Optic Handle and Blade : 040-331U (Mac 1)

The Issue: Laryngoscope handles may not illuminate as intended

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

Class I — Serious Health HazardOngoing
July 11, 2025· Flexicare Medical (Dongguan) Ltd.

Recalled Item: BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle

The Issue: Laryngoscope handles may not illuminate as intended

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

Class I — Serious Health HazardOngoing
July 11, 2025· Remel, Inc

Recalled Item: Blood Agar

The Issue: Listeria Contamination

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

Class II — Potential Health HazardOngoing
July 11, 2025· Remel, Inc

Recalled Item: Blood/MacConkey Biplate 100/PK

The Issue: Listeria Contamination

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

Class II — Potential Health HazardOngoing
July 11, 2025· Remel, Inc

Recalled Item: Strep Selective II Agar

The Issue: Listeria Contamination

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

Class II — Potential Health HazardOngoing
July 11, 2025· Remel, Inc

Recalled Item: Blood/EMB

The Issue: Listeria Contamination

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

Class II — Potential Health HazardOngoing
July 10, 2025· Biofire Defense

Recalled Item: FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative

The Issue: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased

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

Class II — Potential Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: IDM-MICRO-R. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: Micro Joystick R-net. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: All-round Joystick R-net Light. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: IDM-MULTI-R. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: IDM-ARLITE-R. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· mo-Vis BVBA

Recalled Item: Multi Joystick R-net. Electrical wheelchair component.

The Issue: Devices with firmware versions 2.3 and lower may

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

Class I — Serious Health HazardOngoing
July 10, 2025· CareFusion 303, Inc.

Recalled Item: Description/ PYXIS MEDBANK MINI 1FH-1FM/169-137

The Issue: Reports of delayed access to medication in automated

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

Class III — Low RiskOngoing
July 10, 2025· Beckman Coulter, Inc.

Recalled Item: Access Thyroglobulin assay

The Issue: Access Thyroglobulin reagent lot 439163 may generate erroneously

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

Class II — Potential Health HazardOngoing
July 9, 2025· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Chemistry Products Ca Slides

The Issue: Generations 67 and above of VITROS Ca Slides

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

Class II — Potential Health HazardOngoing
July 9, 2025· Encore Medical, LP

Recalled Item: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product

The Issue: Knee implants contain incorrect labeling (size and/or side

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

Class II — Potential Health HazardOngoing