CLASS II Device recall · Reported 11 Feb 2015 · FDA Enforcement Report
Puritan Bennett 980 Ventilator System recalled
Covidien LP (formerly Nellcor Puritan Bennett Inc.) is recalling Puritan Bennett 980 Ventilator System, distributed nationwide in the US. The recall was initiated on 12 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1058-2015
- FDA event ID
- 70239
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2015
- FDA classified
- 5 Feb 2015
- Reported
- 11 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 12 Jan 2015 | Recall initiated by company | |
| 5 Feb 2015 | Classified by FDA | +24 days |
| 11 Feb 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Product as listed by the FDA
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is 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). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types of ventilator support: "Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs) "Assist/ Control, SIMV or Spontaneous modes of ventilation.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Questions about this recall
Is Puritan Bennett 980 Ventilator System recalled?
Yes. Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalled Puritan Bennett 980 Ventilator System on 12 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1058-2015.
Why was it recalled?
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Which lots are affected?
All Puritan Bennett 980 ventilators
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Covidien LP (formerly Nellcor Puritan Bennett Inc.)
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Puritan Bennett 980 Ventilator System, PB980 Ventilator recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | PR |
| Device | CLASS I | Puritan Bennett 980 Ventilator System, Universal recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | OxiMax N-65 Handheld Pulse Oximeter recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
| Device | CLASS II | OxiMax N-560 Pulse Oximeter recalled by Covidien LP (formerly Nellcor | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
| Device | CLASS I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy recalled | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Other | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |