Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to… — Class II medical device recall Z-2628-2023
Ongoing recall by Ambu Inc., reported 2023-10-04, distributed nationwide. Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and u
| Recall number | Z-2628-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2023-07-21 |
| Classified | 2023-09-22 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 2,689 units |
| UPC / GTIN / UDI-DI | 05707480145089 |
| Model numbers | 405011000 |
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
Reason for recall
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
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-2628-2023. 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.