Recall Z-3035-2026
Olympus Corporation of the Americas · initiated August 18, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Reason for recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
FDA-determined cause: Labeling Change Control
Action taken
Olympus notified consignees on 08/18/2026 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were notified of the issue, hazard involved, and that the affected device could still be used. Consignees were instructed to review the recall notification and current inventory for the affected lot number, discard the outer box for any affected units on hand, and attach the recall notification letter to the inner device packaging. Consignees were also instructed to ensure all affected personnel are made aware, to ensure to check the sterile packaging and device labels before use to ensure you are using the correct length for your procedure, notify customers if products were further distributed and complete and return the provided response form.
Details
- Recall number
- Z-3035-2026
- Initiated
- August 18, 2026
- Posted by FDA
- August 26, 2026
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 335 units
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA