Recall Z-3245-2026
Olympus Corporation of the Americas · initiated August 19, 2026
Product
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Codes / lots: Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.
Reason for recall
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-3245-2026
- Initiated
- August 19, 2026
- Posted by FDA
- September 18, 2026
- Product code
- KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Quantity
- 105 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3244-2026 | Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | 08/19/2026Open, Classified |
| Z-3246-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | 08/19/2026Open, Classified |
| Z-3247-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | 08/19/2026Open, Classified |