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Class IIOngoing

Olympus Corporation of the Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long)

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Olympus Corporation of the Americas
Reason
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99607…

Products

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

    Codes/lots: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.Quantity: 335 unitsRecall no. Z-3035-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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