FDA recall Z-3244-2026

Olympus Corporation of the Americas · Class II · device

Product

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Reason for recall

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Key facts

Status
Ongoing
Initiation date
2026-08-19
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3244-2026