Recall Z-0718-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0718-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-04

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-12-04. It names one FDA 510(k) clearance: K221306. Product: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS. Reason: Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient)..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-12-04
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc.·cleared 2023-01-27

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

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Reason for recall

Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).

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