Puritan Bennett 560 Ventilator — Class II medical device recall Z-1775-2022
Ongoing recall by Covidien Llc, reported 2022-09-28, distributed in WA. Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due t
| Recall number | Z-1775-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2022-08-19 |
| Classified | 2022-09-22 |
| Reported by FDA | 2022-09-28 |
| Distributed | WA |
| Quantity | 5 us |
| UPC / GTIN / UDI-DI | 10884521196377 |
| Serial numbers | 40966N7229, 40966N7231, 40966N7334, 40966N7335, 40966N7340 |
Product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Reason for recall
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
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-1775-2022. 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.