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.

Covidien Puritan Bennett 980 Ventilator Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) Due to A software issue may lead to ventilator inoperative...

Date: October 1, 2014
Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Status: Terminated
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 Nellcor Puritan Bennett Inc. (dba Covidien LP) directly.

Affected Products

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.

Quantity: 324 units

Why Was This Recalled?

A software issue may lead to ventilator inoperative situations.

Where Was This Sold?

This product was distributed to 17 states: CA, CO, FL, GA, KY, MA, MN, NY, NC, OH, OK, PA, SC, TN, TX, UT, WI

Affected (17 states)Not affected

About Nellcor Puritan Bennett Inc. (dba Covidien LP)

Nellcor Puritan Bennett Inc. (dba Covidien LP) has 11 total recalls tracked by RecallDetector.

Related Recalls

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