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andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit

GA Health Company Limited · Model 101048 · UDI-DI 04897106958573

ODC OCX Prescription

510(k) clearances

666

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-05-12	Boston Scientific Corporation	Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button
2026-02-12	Olympus Corporation of the Americas	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-02-12	Olympus Corporation of the Americas	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.