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 8001–8020 of 38,428 recalls

May 19, 2023· Baxter Healthcare Corporation

Recalled Item: NaviCare Patient Safety V3.9.200 to 3.9.600

The Issue: Baxter identified a potential risk where the "safety"

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

Class II — Potential Health HazardOngoing
May 19, 2023· Baxter Healthcare Corporation

Recalled Item: Voalte Patient Safety

The Issue: Baxter identified a potential risk where the "safety"

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

Class II — Potential Health HazardOngoing
May 19, 2023· Philips North America Llc

Recalled Item: DigitalDiagnost C90

The Issue: There is a software login in issue that

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

Class II — Potential Health HazardOngoing
May 19, 2023· ARROW INTERNATIONAL Inc.

Recalled Item: ARROW Endurance Extended Dwell Peripheral Catheter System

The Issue: for catheter separation or leakage

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

Class I — Serious Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro...

The Issue: May not meet the stability specifications for shelf

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

Class III — Low RiskOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing
May 18, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Probe Cover Kits containing sterile Ultrasound Gel

The Issue: Probe covers for use during diagnostic ultrasound procedures

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

Class II — Potential Health HazardOngoing