Z-3035-2026Class II

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical...

Name: Z-3035-2026 POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical...
Creator: Olympus Corporation of the Americas
Published: 2026-08-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-08-18 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories on 2026-08-18. FDA classified it as Class II and gives the reason as "Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3035-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-08-26
Recalling firm: OLYMPUS Corporation of the Americas
Product: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Root cause tag: labeling and UDI
FDA 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 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 commerce: 335 units
Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Product codes and lots: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3035-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3035-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26

Product code GEI

K212643Class IIPOWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America / cleared 2021-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)