FDA Device recall Z-2447-2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC CO…
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC CO… by Olympus, citing the air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2447-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-12 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
Reason
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
Identifiers
| code_info | UDI-DI: 04953170355929. All lot numbers |
|---|
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-2447-2023%22
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