Z-3035-2026 Class II Ongoing
FDA device recall Z-3035-2026 was initiated by Olympus Corporation of the Americas on August 18, 2026 and is designated Class II. Reason for recall: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. The recall status is ongoing. Affected quantity: 335 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- August 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335 units
Product Description
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 Pattern
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Code Information
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.