Recall Z-3300-2026— Olympus Corporation of the Americas

Name: FDA recall Z-3300-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-08-24. It names one FDA 510(k) clearance: K890328. Product: Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.. Reason: There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-08-24
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K890328 — ADULT RESECTOSCOPECircon Video·cleared 1990-02-06

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 M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.

Reason for recall

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

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