FDA Medical devices recall ·
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector recall
- Recall number
- Z-3245-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 105 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Why was it recalled?
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3245-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.