FDA Device recall Z-0941-2022
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
- FDA Device
- Class II
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box by Medline Industries Northfield, citing the mask cuff may disconnect from the device's breathing tube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0941-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-09 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Reason
The mask cuff may disconnect from the device's breathing tube.
Identifiers
| code_info | Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UD…Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0941-2022%22
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