Recall Z-3245-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
| Date | Sep 18, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Root cause | Nonconforming Material/Component |
| Action | Olumpus notified consignees on 08/19/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were informed of the reason for recall and hazard involved. Consignees were instructed to examine inventory for affected units, immediately cease use and quarantine them, arrange for their return, and confirm receipt of the recall notification through the portal. Consignees were also instructed to notify customers if product has been further distributed. |
| Quantity | 105 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE Olympus Surgical Technologies America, Dec 14, 2012 |