FDA Device recall Z-1775-2022
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- FDA Device
- Class II
- ongoing
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of Puritan Bennett 560 Ventilator, PB560, CFN 4096600 by Covidien, citing 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 turbin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-19 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | WA |
Product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Reason
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.
Identifiers
| code_info | UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2022%22
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