Recall Z-3245-2026— Olympus Corporation of the Americas

Name: FDA recall Z-3245-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-08-19. It names one FDA 510(k) clearance: K123319. Product: Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.. Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-08-19
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123319 — GYRUS ACMI BICOAG HEMOSTASIS PROBEOlympus Surgical Technologies America·cleared 2012-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.