Recall Z-1167-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1167-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-15

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-12-15. It names one FDA 510(k) clearance: K203277. Product: ESG PK CUTTING FORCEPS, 5MM, 33CM. Reason: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-12-15
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH·cleared 2021-04-28

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

ESG PK CUTTING FORCEPS, 5MM, 33CM

Reason for recall

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

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