FDA recall Z-3035-2026

Olympus Corporation of the Americas · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2026-08-18
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3035-2026