FDA Device Intelligence
HomeAnrei Medical(HZ) Co.,Ltd. › Anrei

Anrei

Anrei Medical(HZ) Co.,Ltd. · Model AMH-EV-01 · UDI-DI 06926839809246

ODC
1
510(k) clearances
666
Adverse events
3
Recalls
77
Facilities

Description

Single Use Endoscope Valves Set

Recalls

DateFirmReason
2026-05-12Boston Scientific CorporationBoston 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
2026-02-12Olympus Corporation of the AmericasThe MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-02-12Olympus Corporation of the AmericasThe MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.