# FDA recall Z-0966-2022

> **Medtronic formerly Covidien** · Class I · device recall initiated 2022-03-25.

## Product

Puritan Bennett 980 Series Ventilator

## Reason for recall

The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

## Distribution

US Nationwide  - Worldwide .Distribution

## Key facts

- **Recall number:** Z-0966-2022
- **Recalling firm:** Medtronic formerly Covidien
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-25
- **Report date:** 2022-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Galway, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2022

## Citation

> AI Analytics. FDA recall Z-0966-2022. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-0966-2022. Source: US FDA. Licensed CC0.

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