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 6641–6660 of 38,428 recalls

November 20, 2023· ResMed Ltd.

Recalled Item: AirTouch N20 Nasal Mask and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 20, 2023· ResMed Ltd.

Recalled Item: AirFit F30 Full Face Mask and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 20, 2023· ResMed Ltd.

Recalled Item: AirFit N10 Nasal Masks and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 20, 2023· ResMed Ltd.

Recalled Item: AirFit F20 Full Face Mask and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 20, 2023· ResMed Ltd.

Recalled Item: AirFit F30i Full Face Mask and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 20, 2023· ResMed Ltd.

Recalled Item: AirFit N20 Nasal Mask and User Guide

The Issue: Masks non-invasive interface for channeling airflow to patients

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

Class I — Serious Health HazardOngoing
November 17, 2023· Draegerwerk Ag & Co. Kgaa

Recalled Item: Atlan

The Issue: Internal backup battery may fail spontaneously while the

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

Class II — Potential Health HazardOngoing
November 17, 2023· Vero Biotech, LLC

Recalled Item: VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette

The Issue: Cassette did not meet an 1n-process flow criterion

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

Class II — Potential Health HazardOngoing
November 17, 2023· Philips North America Llc

Recalled Item: Panorama 1.0T HFO

The Issue: Firm was informed of an event in which

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

Class I — Serious Health HazardOngoing
November 16, 2023· Covidien LP

Recalled Item: AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-

The Issue: Packaging of the device may cause a low

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

Class II — Potential Health HazardOngoing
November 16, 2023· Steris Corporation

Recalled Item: V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty

The Issue: Bandage Scissors handle cover component contains an incorrect

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

Class II — Potential Health HazardOngoing
November 16, 2023· Becton Dickinson & Company

Recalled Item: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe

The Issue: An incorrect stopper was used in nine lots

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

Class II — Potential Health HazardOngoing
November 16, 2023· Covidien

Recalled Item: Covidien Valleylab FT10

The Issue: Due to software issue, New systems may exhibit

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

Class II — Potential Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE TRAY TRACH BASIC SOLUTION

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing
November 15, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline Kits

The Issue: Medline Industries, LP is recalling certain kits and

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

Class I — Serious Health HazardOngoing