Puritan Bennett 980 Series Ventilator — Class I medical device recall Z-0966-2022
Ongoing recall by Medtronic formerly Covidien, reported 2022-05-04, distributed nationwide. The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm stat
| Recall number | Z-0966-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic formerly Covidien, Galway, Ireland |
| Recall initiated | 2022-03-25 |
| Classified | 2022-04-24 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10884521171114, 10884521171121, 10884521171138, 10884521171145, 10884521171244, 10884521171268, 10884521171541, 10884521171558, 10884521171565, 10884521171596, 10884521171602, 10884521171619, 10884521171626, 10884521171633, 10884521171718, 10884521171725, 10884521171732, 10884521171749, 10884521171756, 10884521171763, 10884521171770, 10884521171787, 10884521172166, 10884521172173, 10884521172197 and 76 more |
Product
Puritan Bennett 980 Series Ventilator
Reason for recall
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
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-0966-2022. 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.