FDA Device recall Z-0109-2019
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 by Besmed Health Business, citing ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0109-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-09 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Besmed Health Business |
| Distribution | US |
Product
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Reason
Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Identifiers
| code_info | Lot Numbers: MO0612G40021 and MO0605G40014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.