Puritan Bennett 980 Series Ventilator — Class I medical device recall Z-0344-2022
Terminated recall by Covidien Llc, reported 2021-12-15, distributed nationwide. Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus
| Recall number | Z-0344-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-11-04 |
| Classified | 2021-12-09 |
| Reported by FDA | 2021-12-15 |
| Terminated | 2024-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 278 total |
| UPC / GTIN / UDI-DI | 10884521201545 |
| Serial numbers | 35B1700548, 35B1700551, 35B1700560, 35B1700572, 35B1700577, 35B1700603, 35B1700606, 35B1700615 |
Product
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Reason for recall
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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-0344-2022. 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.