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Olympus Corporation of the Americas: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & acc

Medical DevicesSource: FDA (device) · Date: 2026-09-02

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Reason / hazard
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Recall initiated
2026-08-18
Code info
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Product quantity
335 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
99607
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