FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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.
- Recall number
- Z-1009-2024
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Status
- Open, Classified
- Initiated
- 2024-01-16
- Posted
- 2024-02-07
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- On January 16, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION letters. Customers were instructed to immediately assess all MAJ-2318 at their facility to check the model and lot number. Customers were given detailed instructions on how to identify affected product, including for MAJ-2318 installed in the OER machine. Please contact your Olympus customer service representative at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return any affected product. Customers who have further distributed product should notify downstream accounts at once. If you require assistance with identifying affected product, please contact the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
- Quantity
- 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
- Distribution
- Domestic US distribution nationwide.
- Lot, serial or model codes
- UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)
- 510(k) numbers
- ["K103264"]
- PMA numbers
- not on file
- Product code
- FEB
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28