Recall Z-1815-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1815-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-12

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-08-12. It names one FDA 510(k) clearance: K212643. Product: Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.. Reason: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-08-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K212643 — POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America·cleared 2021-09-27

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

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Reason for recall

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

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