Recall Z-1009-2024 ยท FEB Accessories, Cleaning, For Endoscope
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.
| Date | Feb 7, 2024 (initiated Jan 16, 2024) |
| Status | Open, Classified |
| 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 downst |
| Quantity | 877 MAJ-2318, 119 OER-Elite, 3 OER-MINI |
| Distribution | Domestic US distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO Olympus Medical Systems Corporation, Feb 23, 2011 |