POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
FDA Recall Z-3035-2026 · Posted 2026-08-26
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2026-08-18
Product Quantity335 units
Reason for Recall
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Firm 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 are using the correct length for your procedure, notify customers if products were further distributed and complete and return the provided response form.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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