Recall Z-1489-2026 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
| Date | Mar 3, 2026 (initiated Jan 29, 2026) |
| Status | Open, Classified |
| Reason | Potential for rubber fragment detachment during use. |
| Root cause | Under Investigation by firm |
| Action | Olympus notified consignees on about 01/29/2026 via letter titled URGENT: FIELD SAFETY NOTICE. Consignees were instructed to carefully read the content of the notification, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, and that they may continue using the devices as per the notification and instructions for use. Olympus is highlighting the importance of strictly adhering to the Inspection of the Biopsy Valve and Inserting and Withdrawing the Endo-therapy accessories sections in the IFU related to the detachment of fragment |
| Quantity | 1,276 boxes (20 units per box) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061313 | EVIS EXERA 180 SYSTEM Olympus Medical Systems Corporation, Aug 31, 2006 |