Ambu aView 2 A Monitor — Class II medical device recall Z-0714-2024
Ongoing recall by Ambu Inc., reported 2024-01-17, distributed nationwide. Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14
| Recall number | Z-0714-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2023-12-05 |
| Classified | 2024-01-11 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 11,845 distributed |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05707480145089, 05707480156757 |
| Model numbers | 405011000, 405011000US2 |
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Reason for recall
Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
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-0714-2024. 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.