Olympus Endoscope Suction Valve — Class II medical device recall Z-1610-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-04-01, distributed nationwide. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endos
| Recall number | Z-1610-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2026-02-12 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 47,383 units |
| UPC / GTIN / UDI-DI | 04953170355912 |
| Model numbers | MAJ-1443, N5363430 |
Product
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Reason for recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1610-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.