Recall archive / FDA device enforcement
Puritan Bennett 560 Ventilator, PB560, CFN 4096600 — FDA record Z-1775-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Covidien Llc
- Quantity
- 5 US
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1775-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 28, 2022
- Recall initiation date
- Aug 19, 2022
- Center classification date
- Sep 22, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.