Olympus recallZ-3035-2026 · Olympus Corporation of the Americas · initiated Aug 18, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-3035-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2026
- Posted by the FDA
- Aug 26, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 335 units
- Product code
- GEI
- FDA submissions
- K212643
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Product description
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Code information (models, lots, serial numbers)
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Olympus PS-0523CJDAGyrus ACMI, LLC · Electrosurgical, cutting & coagulation & accessories3 recalls90 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K212643 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Olympus PS-0537CJDAGyrus ACMI, LLC · Electrosurgical, cutting & coagulation & accessories2 recalls184 reports
- Olympus PS-0544CJDAGyrus ACMI, LLC · Electrosurgical, cutting & coagulation & accessories2 recalls10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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