Water Filter MAJ-2318 — Class II medical device recall Z-1009-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-02-14, distributed nationwide. Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessin
| Recall number | Z-1009-2024 |
|---|---|
| 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 | 2024-01-16 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04953170401473 |
| Lot numbers | 36A, 37A, 38A |
Product
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
Reason for recall
Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
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-1009-2024. 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.