Ambu aScope" 5 Broncho HD 5 — Class II medical device recall Z-1723-2025
Ongoing recall by Ambu Inc., reported 2025-05-14, distributed nationwide. Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The
| Recall number | Z-1723-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2025-04-07 |
| Classified | 2025-05-06 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 160 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05707480156542 |
| Lot numbers | 1001080963 |
| Model numbers | 622002000US |
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Reason for recall
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
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-1723-2025. 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.