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 1001–1020 of 38,428 recalls

October 1, 2025· Medline Industries, LP

Recalled Item: Medline RenewalLigasure Blunt Tip Sealer/Divider

The Issue: Medline Renewal has determined that certain areas on

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

Class II — Potential Health HazardOngoing
October 1, 2025· Philips Medical Systems DMC GmbH

Recalled Item: CombiDiagnost R90

The Issue: Philips has identified that some ceiling suspension telescopic

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

Class II — Potential Health HazardOngoing
October 1, 2025· Medline Industries, LP

Recalled Item: Medline Renewal LigaSure Exact

The Issue: Medline Renewal has determined that certain areas on

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

Class II — Potential Health HazardOngoing
October 1, 2025· Medline Industries, LP

Recalled Item: Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider

The Issue: Medline Renewal has determined that certain areas on

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

Class II — Potential Health HazardOngoing
October 1, 2025· Medline Industries, LP

Recalled Item: Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated

The Issue: Medline Renewal has determined that certain areas on

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

Class II — Potential Health HazardOngoing
October 1, 2025· Siemens Medical Solutions USA, Inc

Recalled Item: MAGNETOM Cima.X Upgrade. Model Number: 11689304.

The Issue: There is a potential for an ice blockage

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

Class I — Serious Health HazardOngoing
October 1, 2025· Medline Industries, LP

Recalled Item: Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated

The Issue: Medline Renewal has determined that certain areas on

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

Class II — Potential Health HazardOngoing
October 1, 2025· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost 4 (1) High Performance

The Issue: Philips has identified that some ceiling suspension telescopic

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

Class II — Potential Health HazardOngoing
October 1, 2025· Beckman Coulter, Inc.

Recalled Item: Beckman Coulter UniCel DxI 600

The Issue: An internal investigation has determined that due to

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

Class II — Potential Health HazardOngoing
October 1, 2025· Beckman Coulter, Inc.

Recalled Item: Beckman Coulter UniCel DxI 800

The Issue: An internal investigation has determined that due to

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

Class II — Potential Health HazardOngoing
October 1, 2025· ENDOMAGNETICS LTD

Recalled Item: Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12.

The Issue: for contamination with cotton fibers

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

Class II — Potential Health HazardOngoing
October 1, 2025· Microgenics Corporation

Recalled Item: Thermo scientific MAS Omni CARDIO

The Issue: The firm received complaints from customers reporting vial-to-vial

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

Class II — Potential Health HazardOngoing
October 1, 2025· ENDOMAGNETICS LTD

Recalled Item: Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07.

The Issue: for contamination with cotton fibers

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

Class II — Potential Health HazardOngoing
October 1, 2025· Abiomed, Inc.

Recalled Item: Automated Impella Controller (AIC)

The Issue: cybersecurity vulnerabilities related to the operating system

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

Class I — Serious Health HazardOngoing
September 30, 2025· SHENZHEN ATOMSTACK TECHNOLOGIES

Recalled Item: Material Processing Laser Products

The Issue: Lack of Remote Interlock Connector - required per

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) ACH PLASTICS BREAST-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: CIRCUMCISION 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) MINOR EYE TRAY #81

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) CENTRAL LINE 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: GP-LEEP 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