Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Puritan Bennett 980 Series Ventilator Recalled by Medtronic formerly Covidien Due to The audible alarm may not sound and/or the...

Date: March 25, 2022
Company: Medtronic formerly Covidien
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic formerly Covidien directly.

Affected Products

Puritan Bennett 980 Series Ventilator

Quantity: 18,508 OUS; 18,412 US

Why Was This Recalled?

The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic formerly Covidien

Medtronic formerly Covidien has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report