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 5021–5040 of 38,428 recalls

May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Hand Pack convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Biopsy Drape Pack convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Laparoscopy Litho Std Pack convenience kit and

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Special Procedure Pack convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Cataract Pack convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Extremity convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· American Contract Systems, Inc.

Recalled Item: American Contract Systems Gyn Laparoscopy convenience kit

The Issue: Product released with insufficient aeration time impacting the

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

Class II — Potential Health HazardOngoing
May 6, 2024· NovaSignal Corp.

Recalled Item: NovaGuide 2 Traditional Ultrasound

The Issue: Due to inadvertently disconnecting grounding cable of ultrasound

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

Class II — Potential Health HazardOngoing
May 6, 2024· NovaSignal Corp.

Recalled Item: NovaGuide 2 Intelligent Ultrasound

The Issue: Due to inadvertently disconnecting grounding cable of ultrasound

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

Class II — Potential Health HazardOngoing
May 3, 2024· MicroPort Orthopedics Inc.

Recalled Item: EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee...

The Issue: One confirmed incident has been received that EFSRN4PR,

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Philips North America Llc

Recalled Item: HA FlexTrak II-Patient transport functionality to transport the patient from

The Issue: Oil may leak from the HA FlexTrack Trolley

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: FLIXENE

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: ADVANTA VXT

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: FLIXENE

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing
May 3, 2024· Atrium Medical Corporation

Recalled Item: FLIXENE

The Issue: Complaints of reported separation of the Slider GDS

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

Class II — Potential Health HazardOngoing