Recall Z-3035-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
| Date | Aug 26, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| Reason | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 335 units |
| Distribution | Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Surgical Technologies America, Sep 27, 2021 |