# FDA recall Z-2450-2023

> **Mallinckrodt Manufacturing LLC** · Class I · device recall initiated 2023-08-08.

## Product

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

## Reason for recall

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-2450-2023
- **Recalling firm:** Mallinckrodt Manufacturing LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-08
- **Report date:** 2023-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2023

## Citation

> AI Analytics. FDA recall Z-2450-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2450-2023. Source: US FDA. Licensed CC0.

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