FDA Device recall Z-1723-2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set by Ambu, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1723-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-07 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ambu |
| Distribution | US |
Product
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Reason
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.
Identifiers
| code_info | Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1723-2025%22
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