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 341–360 of 38,428 recalls

December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT...

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) SMJ LAP

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) CATH LAB

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) PACER /

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· NIPRO Technical Services, Inc.

Recalled Item: Conductivity Standard Solution Catalog/Model Numbers: 10001

The Issue: due to a defect associated with the conductivity

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

Class II — Potential Health HazardOngoing
December 12, 2025· Medline Industries, LP

Recalled Item: Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK

The Issue: Medline kits were manufactured and distributed containing MASTISOL

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

Class II — Potential Health HazardOngoing
December 12, 2025· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Philips Azurion system

The Issue: Philips has identified two (2) software issues affecting

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

Class II — Potential Health HazardOngoing
December 12, 2025· Hologic, Inc

Recalled Item: ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

The Issue: Fungal contamination of affected lot with Parengyodontium album

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

Class II — Potential Health HazardOngoing
December 12, 2025· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes

The Issue: Six (6) identified software issues which may result

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

Class II — Potential Health HazardOngoing
December 12, 2025· Integra LifeSciences Corp. (NeuroSciences)

Recalled Item: Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the

The Issue: corrosion stains on the surface of the

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

Class II — Potential Health HazardOngoing