# FDA recall Z-1775-2022

> **Covidien Llc** · Class II · device recall initiated 2022-08-19.

## 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.

## Distribution

Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1775-2022
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-19
- **Report date:** 2022-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2022

## Citation

> AI Analytics. FDA recall Z-1775-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1775-2022. Source: US FDA. Licensed CC0.

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