Recall Z-1481-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1481-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-05

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-01-05. It names one FDA 510(k) clearance: K123319. Product: Hemostasis Probe, Model: CD-B622LA. Reason: The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-01-05
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

Hemostasis Probe, Model: CD-B622LA

Reason for recall

The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

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