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FDA · Medical devices ·

POWERSEAL 5 MM (in diameter) 23 CM (long) recall

Olympus Corporation of the Americas recalled POWERSEAL 5 MM (in diameter) 23 CM (long) on September 2, 2026 because of potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 335 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Olympus Corporation of the Americas, Center Valley, PA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Status
Ongoing
Recall number
Z-3035-2026
Source
U.S. Food and Drug Administration

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