CLASS I Device recall · Reported 26 Aug 2015 · FDA Enforcement Report
Puritan Bennett 980 Ventilator System, Universal recalled
Covidien LP (formerly Nellcor Puritan Bennett Inc.) is recalling Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled), distributed nationwide in the US. The recall was initiated on 16 Jul 2015 and the FDA has classified it as Class I.
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-2329-2015
- FDA event ID
- 71675
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Jul 2015
- FDA classified
- 14 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- CPAP & Ventilators
Timeline
| 16 Jul 2015 | Recall initiated by company | |
| 14 Aug 2015 | Classified by FDA | +29 days |
| 26 Aug 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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).
Where it was distributed
Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
Questions about this recall
Is Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) recalled?
Yes. Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalled Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) on 16 Jul 2015. The recall is Class I and its status is Terminated. Recall number Z-2329-2015.
Why was it 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.
Which lots are affected?
PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS
Where was it sold?
Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 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 |
| 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 |