Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1814-2022 — Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

U.S. FDA — Device Enforcement · United States · 2022-08-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1814-2022
Date of alert
2022-08-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00821925044555
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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