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 3241–3260 of 38,428 recalls

November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument

The Issue: The probe tips of the hand instruments are

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

Class II — Potential Health HazardOngoing
November 25, 2024· Angiodynamics, Inc.

Recalled Item: AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number:

The Issue: for procedural delays or interruptions during use

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

Class II — Potential Health HazardOngoing
November 25, 2024· GE Medical Systems, LLC

Recalled Item: GE Healthcare Optima XR240amx

The Issue: GE HealthCare has become aware that in certain

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

Class II — Potential Health HazardOngoing
November 25, 2024· GE Medical Systems, LLC

Recalled Item: GE Healthcare Optima XR220amx

The Issue: GE HealthCare has become aware that in certain

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

Class II — Potential Health HazardOngoing
November 25, 2024· Spacelabs Healthcare, Inc.

Recalled Item: Xhibit Telemetry Receiver

The Issue: Telemetry receiver systems may experience a Windows proxy

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

Class II — Potential Health HazardOngoing
November 25, 2024· Spacelabs Healthcare, Inc.

Recalled Item: Xhibit Telemetry Receiver with Software

The Issue: Telemetry receivers with affected software versions may experience

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

Class II — Potential Health HazardOngoing
November 25, 2024· Spacelabs Healthcare, Ltd.

Recalled Item: Eclipse PRO The Spacelabs model 98700 is a

The Issue: Due to a manufacturing error the incorrect device

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

Class II — Potential Health HazardOngoing
November 25, 2024· Spacelabs Healthcare, Ltd.

Recalled Item: Eclipse Mini The Eclipse MINI Model 98900 is

The Issue: Due to a manufacturing error the incorrect device

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

Class II — Potential Health HazardOngoing
November 25, 2024· Spectranetics Corporation

Recalled Item: Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code

The Issue: Due to complaints received for the marker band

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

Class II — Potential Health HazardOngoing
November 24, 2024· Adept Medical Ltd

Recalled Item: Otological Ventilation Tube - T-Tube 9mm - Silicone

The Issue: Lack of 510(k) clearance

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

Class II — Potential Health HazardOngoing