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 221–240 of 38,428 recalls

December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

The Issue: A smaller open suction catheter, the 8 Fr

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

Class II — Potential Health HazardOngoing
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: STERILE RESUTURE 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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: ANESTHESIA ARTLINE 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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY

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
December 24, 2025· Medline Industries, LP

Recalled Item: Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

The Issue: A smaller open suction catheter, the 8 Fr

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

Class II — Potential Health HazardOngoing
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT

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
December 24, 2025· Medline Industries, LP

Recalled Item: 1) UNIVERSAL KIT

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG

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
December 24, 2025· Medline Industries, LP

Recalled Item: Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY

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
December 24, 2025· Zimmer Surgical Inc

Recalled Item: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet

The Issue: Device user interface (screen) may freeze or become

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

Class II — Potential Health HazardOngoing
December 24, 2025· Zimmer Surgical Inc

Recalled Item: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet

The Issue: Device user interface (screen) may freeze or become

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

Class II — Potential Health HazardOngoing
December 24, 2025· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Omni Legend

The Issue: There is a potential intermittent issue on certain

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

Class II — Potential Health HazardOngoing
December 23, 2025· Focalyx Technologies, LLC.

Recalled Item: Focalyx Fusion

The Issue: Software device that is an accessory for image-guided

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

Class II — Potential Health HazardOngoing
December 23, 2025· Beckman Coulter, Inc.

Recalled Item: CellMek SPS Sample Preparation System

The Issue: Sample preparation system designed to automate staining, lysing,

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

Class II — Potential Health HazardOngoing
December 22, 2025· Medline Industries, LP

Recalled Item: Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry...

The Issue: These lots of reprocessed catheters may contain small

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

Class I — Serious Health HazardOngoing
December 22, 2025· Medline Industries, LP

Recalled Item: Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10

The Issue: These lots of reprocessed catheters may contain small

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

Class I — Serious Health HazardOngoing