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FDAMarch 7, 2024device

POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044555

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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