Class II — Ambu Inc.
| Recalling firm | Ambu A/S |
|---|---|
| Registered facility | AMBU INNOVATION GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames |
| Product | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000 |
| Quantity | 2689 units |
| Distribution | Nationwide |
| Initiated | 2023-07-21 |
| Classified | 2023-09-22 |
| Recall number | Z-2628-2023 |
| 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-2628-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92886/
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