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.
This recall is currently active, issued February 7, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- January 16, 2024
- Posted
- February 7, 2024
- Recall Number
- Z-1009-2024
- Quantity
- 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic US distribution nationwide.
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)
Root Cause
Process control
Action Taken
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.