Mallinckrodt One-Way Valve — Class I medical device recall Z-2450-2023
Ongoing recall by Mallinckrodt Manufacturing LLC, reported 2023-09-20. The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
| Recall number | Z-2450-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Manufacturing LLC, Madison, WI, United States |
| Recall initiated | 2023-08-08 |
| Classified | 2023-09-08 |
| Reported by FDA | 2023-09-20 |
| Quantity | 13,602 units |
| UPC / GTIN / UDI-DI | 10810055283467 |
| Lot numbers | 74B2100237, 74L2001714, 74L2001715, 74L2001716, 74M2001125 |
| Model numbers | 50412, 91346 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2450-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.