Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection
Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving risk-of-harm to patients from potentially contaminated endoscopes, with no reported illnesses or injuries to date.
Plain-English summary
The Olympus MAJ-2318 water filter is designed for use with Olympus endoscope reprocessors (OER-ELITE and OER-MINI models) to prevent contamination of rinse water. Approximately 877 MAJ-2318 filters have been distributed nationwide in the United States.
The MAJ-2318 water filter may have been assembled incorrectly. This defect could result in unfiltered tap water being used during endoscope reprocessing instead of properly filtered water.
Improper use of unfiltered water could expose patients to potentially contaminated endoscopes, presenting a risk of infection or sepsis.
The recalled product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- assembly-defect
- contaminated-water
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 04953170401473 Lots 36A
- 37A
Distribution
Distributed nationwide across the United States.
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