Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Puritan Bennett 980 Ventilator System Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) Due to Graphical user interface (GUI) unresponsive to touch and...

Date: January 15, 2016
Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
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 Covidien LP (formerly Nellcor Puritan Bennett Inc.) directly.

Affected Products

Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.

Quantity: 1,864 units

Why Was This Recalled?

Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.

Where Was This Sold?

Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.

About Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Covidien LP (formerly Nellcor Puritan Bennett Inc.) has 7 total recalls tracked by RecallDetector.

Related Recalls

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