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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — device enforcement reference
Source observed: 8/18/2026, 12:00:00 AM UTC
Source updated: 8/26/2026, 12:00:00 AM UTC
Location: Center Valley, PA, US
hazard: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
event number: 99607
manufacturer: Olympus Corporation of the Americas
recall number: Z-3035-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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