FDA Medical Device · Z-3035-2026

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Class II · Ongoing

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Affected lots / codes — check yours against thisModel Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.

Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 335 units
Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Recall initiated: August 18, 2026
Classified: August 26, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3035-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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