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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · assembly defect
See all →- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
Similar recalls
- HighEndoscope Reprocessor Tubing Assembly Error May Reduce Disinfection Effectiveness
FDA (Devices) · 2022-02-23
- ModerateOER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
FDA (Devices) · 2026-04-29
- ModerateOlympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
FDA (Devices) · 2026-04-29
- SevereOlympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing
FDA (Devices) · 2025-01-22
- ModerateOER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
FDA (Devices) · 2026-04-29
- ModerateOER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
FDA (Devices) · 2026-04-29