Z-1009-2024 Class II Ongoing
FDA device recall Z-1009-2024 was initiated by Olympus Corporation Of The Americas on Jan 16, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 14, 2024
- Initiation Date
- Jan 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
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.
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.
Distribution Pattern
Domestic US distribution nationwide.
Code Information
UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1009-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026