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 1021–1040 of 38,428 recalls

September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as LOCAL BASIC

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: PORT INSERTION PACK

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) HEAD AND NECK

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Medline Industries, LP

Recalled Item: MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
September 30, 2025· Prismatik Dentalcraft, Inc.

Recalled Item: Inclusive Product Name: Inclusive Titanium Screw compatible with:

The Issue: Incorrect titanium screw, packaged with dental implant

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

Class II — Potential Health HazardOngoing
September 30, 2025· Elekta, Inc.

Recalled Item: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic

The Issue: Due to increased risk that paint flakes from

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

Class II — Potential Health HazardOngoing
September 30, 2025· Alcon Research LLC

Recalled Item: Alcon PRECISION1 One-Day Contact Lenses

The Issue: for a weak seal in some units

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

Class II — Potential Health HazardOngoing
September 30, 2025· IMPRIS Imaging Inc

Recalled Item: IMRIS Operating Suite

The Issue: There is a potential safety issue associated with

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

Class I — Serious Health HazardOngoing
September 30, 2025· IMPRIS Imaging Inc

Recalled Item: IMRIS Operating Suite

The Issue: There is a potential safety issue associated with

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

Class I — Serious Health HazardOngoing