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 Ventilator System Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) Due to Reports in which tidal volumes reaching patients were...
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, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
Quantity: 657 units
Why Was This Recalled?
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Covidien LP (formerly Nellcor Puritan Bennett Inc.) has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report