Class II

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

Olympus Corporation of the Americas · August 18, 2026

Reason for Recall

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

Distribution

Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.

States Affected

NATIONWIDE

Quantity Affected

335 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3035-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.