Z-3245-2026 Class II Ongoing
FDA device recall Z-3245-2026 was initiated by Olympus Corporation Of The Americas on Aug 19, 2026 and is designated Class II. Reason for recall: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. The recall status is ongoing. Affected quantity: 105 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 units
Product Description
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Reason for Recall
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Code Information
Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.