Recall Z-0568-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0568-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-02

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-10-02. It names one FDA 510(k) clearance: K890328. Product: ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,. Reason: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-10-02
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

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

Reason for recall

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

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