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 141–160 of 38,428 recalls

January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) OPEN HEART CDS

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) OR ARTERIOGRAM

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) C-SECTION PACK

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) KIT UROLOGY SLING

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) SPINAL CDS

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Surgical Drapes: 1) SHEET

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) CHEST/BREAST-LF

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) DRAPE PACK

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Medline Industries, LP

Recalled Item: Medline Convenience Kits: 1) SCC RF PAIN MGMT

The Issue: Medline has identified issues related to calibration of

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

Class II — Potential Health HazardOngoing
January 7, 2026· Philips North America Llc

Recalled Item: Brilliance iCT

The Issue: As part of the CT systems sub assembly,

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

Class II — Potential Health HazardOngoing
January 7, 2026· Philips North America Llc

Recalled Item: Spectral CT

The Issue: As part of the CT systems sub assembly,

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

Class II — Potential Health HazardOngoing
January 7, 2026· Philips North America Llc

Recalled Item: IQon Spectral CT

The Issue: As part of the CT systems sub assembly,

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

Class II — Potential Health HazardOngoing
January 7, 2026· Philips North America Llc

Recalled Item: Spectral CT 7500 on Rails

The Issue: As part of the CT systems sub assembly,

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

Class II — Potential Health HazardOngoing
January 7, 2026· Olympus Corporation of the Americas

Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...

The Issue: Devices which did not undergo thermoforming could deform

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

Class II — Potential Health HazardOngoing
January 7, 2026· Olympus Corporation of the Americas

Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...

The Issue: Devices which did not undergo thermoforming could deform

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

Class II — Potential Health HazardOngoing
January 7, 2026· Olympus Corporation of the Americas

Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...

The Issue: Devices which did not undergo thermoforming could deform

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

Class II — Potential Health HazardOngoing
January 7, 2026· Olympus Corporation of the Americas

Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...

The Issue: Devices which did not undergo thermoforming could deform

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

Class II — Potential Health HazardOngoing
January 7, 2026· Olympus Corporation of the Americas

Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...

The Issue: Devices which did not undergo thermoforming could deform

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

Class II — Potential Health HazardOngoing