Z-1009-2024Class II

Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope...

Name: Z-1009-2024 Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope...
Creator: Olympus Corporation of the Americas
Published: 2024-01-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-01-16 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2024-01-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1009-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-16
Posted: 2024-02-07
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.
Product code: FEB Accessories, Cleaning, For Endoscope
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.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
Distribution: Domestic US distribution nationwide.
Product codes and lots: UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-07

Product code FEB

K103264Class IIEndoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation / cleared 2011-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)