Recall record at a glance
| Official record | Z-1009-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Olympus Corporation of the Americas |
| Report date | Feb 14, 2024 |
| Recall initiation date | Jan 16, 2024 |
| Quantity | 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI |
| Location | Center Valley, PA, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
Domestic US distribution nationwide.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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