Puritan Bennett 980 Ventilator System — Class II medical device recall Z-1181-2016
Terminated recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), reported 2016-03-23, distributed in PR. Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstanc
| Recall number | Z-1181-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.), Boulder, CO, United States |
| Recall initiated | 2016-01-15 |
| Classified | 2016-03-16 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-07-11 |
| Distributed | PR |
| Countries outside the US | AE, AR, AU, BH, BR, CL, CO, CR, EG, IE, IL, JO, JP, KW, LB, MA, MX, PA, PE, QA, RO, RU, SA, SG, SI, TR, UY, ZA |
| Quantity | 1,864 units |
Product
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.
Reason for recall
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.
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-1181-2016. 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.