Class II — Ambu Inc.
| Recalling firm | Ambu A/S |
|---|---|
| Registered facility | AMBU INNOVATION GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications. |
| Product | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. |
| Quantity | Total Numbers of unit distributed: 45990 pes (USA) |
| Distribution | Please see attached consignee list |
| Initiated | 2016-02-10 |
| Classified | 2016-03-24 |
| Terminated | 2016-06-22 |
| Recall number | Z-1236-2016 |
| 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 — Ambu Inc. (Z-1236-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73366/
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