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 981–1000 of 38,428 recalls

October 6, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Single Use Electrosurgical Snare SD-400 Product Name:

The Issue: Sterility compromised from small holes that may occur

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

Class II — Potential Health HazardOngoing
October 6, 2025· Applied Medical Technology Inc

Recalled Item: Applied Medical Technology

The Issue: The nasal feeding tube may be occluded

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

Class II — Potential Health HazardOngoing
October 6, 2025· Tandem Diabetes Care, Inc.

Recalled Item: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are...

The Issue: Insulin pump includes a vibration motor that gives

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

Class I — Serious Health HazardOngoing
October 3, 2025· Medtronic Perfusion Systems

Recalled Item: MC3 VitalFlow Console

The Issue: As of August 6, 2025, Medtronic has received

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

Class II — Potential Health HazardOngoing
October 3, 2025· Medline Industries, LP

Recalled Item: MEDLINE STERILE BASIC EYE PACK 16: 1)

The Issue: Medline has identified specific sterile eye procedure kits

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

Class II — Potential Health HazardOngoing
October 3, 2025· Integra LifeSciences Corp. (NeuroSciences)

Recalled Item: TruDi¿ Navigation System - Multi Instrument Adapter

The Issue: It was determined that when the navigation system

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

Class II — Potential Health HazardOngoing
October 2, 2025· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number:

The Issue: The motorized longitudinal movement of the FlexArm stand

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

Class II — Potential Health HazardOngoing
October 2, 2025· Cerenovus Inc

Recalled Item: CEREPAK Detachable Coil System - Name/ 2MM X 2.5 CM/FCX100202

The Issue: Detachable coils system may fail to detach, which

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

Class I — Serious Health HazardOngoing
October 2, 2025· ICU Medical, Inc.

Recalled Item: IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave

The Issue: IV Gravity burette administration set burette component is

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

Class I — Serious Health HazardOngoing
October 1, 2025· Quest International, Inc.

Recalled Item: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme

The Issue: Due to distributing the measles IgG IVD without

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: Radiography 7300 C

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 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· Medline Industries, LP

Recalled Item: Medline Renewal Ligasure Impact 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· Philips Medical Systems DMC GmbH

Recalled Item: DigitalDiagnost C90 (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· Medline Industries, LP

Recalled Item: Medline Renewal LigaSure Small Jaw Instrument (Purple/White)

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 Blunt Tip 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· Philips Medical Systems DMC GmbH

Recalled Item: Precision CRF

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 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· Medline Industries, LP

Recalled Item: Medline Renewal Ligasure Blunt Tip 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· Philips Medical Systems DMC GmbH

Recalled Item: ProxiDiagnost N90

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