Ambu Aura40 Standard — Class II medical device recall Z-0109-2019
Terminated recall by Besmed Health Business Corporation, reported 2018-10-24, distributed nationwide. Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Lar
| Recall number | Z-0109-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Besmed Health Business Corporation, New Taipei City, N/A, Taiwan |
| Recall initiated | 2018-08-09 |
| Classified | 2018-10-15 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 267 units |
| Reason classes | sterility |
| Lot numbers | MO0605G40014, MO0612G40021 |
| Model numbers | 340300000 |
Product
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Reason for recall
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
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-0109-2019. 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.