Class II — Besmed Health Business Corporation
| Recalling firm | BESMED HEALTH BUSINESS CORP. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile |
| Product | Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 |
| Quantity | 267 units |
| Distribution | US Nationwide, and country of Canada. |
| Initiated | 2018-08-09 |
| Classified | 2018-10-15 |
| Terminated | 2019-05-10 |
| Recall number | Z-0109-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Besmed Health Business Corporation (Z-0109-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81009/
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