FDA Device recall Z-0340-2024
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management by Aizu Olympus, citing channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0340-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aizu Olympus |
| Distribution | US |
Product
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Reason
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Identifiers
| code_info | Model Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0340-2024%22
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