—#205621

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.

FDA product code: FEB — Accessories, Cleaning, For Endoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K103264
Affected lot / code info: UDI-DI 04953170401473 Lots 36A, 37A, 38A Affected product may have also been packaged within OER boxes (OER-Elite and OER-MINI)

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Domestic US distribution nationwide.

Timeline

Recall initiated: 2024-01-16
Posted by FDA: 2024-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.