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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus PowerSeal

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 Class 2 Device Recall Olympus PowerSealsee related information
Date Initiated by FirmAugust 18, 2026
Date PostedAugust 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3035-2026
Recall Event ID 99607
510(K)NumberK212643 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductPOWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Code Information Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Troiani
484-5531029
Manufacturer Reason
for Recall		Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
FDA Determined
Cause 2		Labeling Change Control
ActionOlympus 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.
Quantity in Commerce335 units
DistributionWorldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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