Puritan Bennett 980 Ventilator System — Class I medical device recall Z-2329-2015
Terminated recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), reported 2015-08-26, distributed nationwide. Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control
| Recall number | Z-2329-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO, United States |
| Recall initiated | 2015-07-16 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BH, BR, CA, CL, CO, CR, EG, IE, IL, JO, JP, KW, LB, MA, MX, PA, PE, QA, RU, SA, SG, SI, TR, UY, ZA |
| Quantity | 657 units |
Product
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2329-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.