---
title: "Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #... — FDA record Z-2450-2023 | Is It on Recall"
description: "The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen."
url: https://isitonrecall.com/recall/fda-device-z-2450-2023-mallinckrodt-one-way-valve-22f-x-22m-a-part-91346-1-piece-and-b-part-50412-pack-of-5-used-with-venti/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. — FDA record Z-2450-2023

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 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
- **Reason**: The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
- **Classification**: Class I
- **Recalling firm**: Mallinckrodt Manufacturing LLC
- **Quantity**: 13,602 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2450-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2450-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | a) UDI/DI 10810055283460, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237; b) UDI/DI 10810055283467, Lot Codes: 74L2001714, 74L2001715, 74L2001716, 74M2001125, 74B2100237 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide Distribution

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 20, 2023
- **Recall initiation date**: Aug 8, 2023
- **Center classification date**: Sep 8, 2023

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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2450-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Mallinckrodt Manufacturing LLC records](https://isitonrecall.com/brand/mallinckrodt-manufacturing-llc/)