Official recall record

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC CO

US FDA — Medical Devices · 2023-07-12 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-07-12
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 04953170355929
Brand on record: Olympus Corporation of the Americas

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2026-02-12 · US FDA — Medical Devices
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

Other recalls from this brand

All 21 official recall notices naming Olympus Corporation of the Americas on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.