Medline Standard PVC Laryngeal Masks — Class II medical device recall Z-0941-2022
Terminated recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-04-20, distributed nationwide. The mask cuff may disconnect from the device's breathing tube.
| Recall number | Z-0941-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-03-09 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2026-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 8,990 cases |
| UPC / GTIN / UDI-DI | 10193489036688, 10193489036695, 10193489036701, 10193489036718, 10193489036725, 10193489036732, 10193489036749 |
| Lot numbers | 63521050001, 63521050002, 63521100002, 63521110001, DYND290010 |
Product
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Reason for recall
The mask cuff may disconnect from the device's breathing tube.
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-0941-2022. 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.