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 3401–3420 of 38,428 recalls

November 6, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand

The Issue: Surgical Patties & Surgical Strips in specific lots

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

Class II — Potential Health HazardOngoing
November 6, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand

The Issue: Surgical Patties & Surgical Strips in specific lots

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

Class II — Potential Health HazardOngoing
November 6, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MAJOR NEURO PACK-LF Convenience kit

The Issue: Surgical Patties & Surgical Strips in specific lots

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

Class II — Potential Health HazardOngoing
November 6, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand

The Issue: Surgical Patties & Surgical Strips in specific lots

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

Class II — Potential Health HazardOngoing
November 6, 2024· ICU Medical, Inc.

Recalled Item: ChemoLock Close Vial Spike The Chemolock Closed System

The Issue: Due to finished goods incorrectly packaged and labeled

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

Class II — Potential Health HazardOngoing
November 6, 2024· Becton Dickinson & Co.

Recalled Item: BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro

The Issue: BD identified through potency testing as part of

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

Class II — Potential Health HazardOngoing
November 5, 2024· NOA Medical Industries Inc

Recalled Item: NOA Medical Industries Behavioral Health Hospital bed side rails

The Issue: Red button used to engage side rails can

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Advance

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· Microline Surgical, Inc.

Recalled Item: Microscissor Tip (Disposable)

The Issue: A lot of ReNew Microscissor Tips exhibited a

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution ACE

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Optima 680 Expert

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Eagle

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Discovery RT

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Frontier

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Maxima Select

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Operator Console Upgrade Types

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Ascend Elite

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Ascend

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution Maxima M

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing
November 5, 2024· GE Healthcare (China) Co., Ltd.

Recalled Item: GE Healthcare Revolution EVO

The Issue: GE HealthCare has become aware of a potential

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

Class II — Potential Health HazardOngoing