FDA recall, , Moderate risk
Olympus POWERSEAL Curved Jaw Sealer & Divider
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall on August 18, 2026, of its POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action, GEI / Electrosurgical, cutting & coagulation & accessories product due to a potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
The recall involves 335 units and was added to the FDA's Enforcement Report on August 26, 2026. Distribution includes the U.S. states of Kansas and Florida, and the countries of Australia, the European Union, and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
POWERSEAL 5 mm (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
- UDI-DI
- 00821925044531
- Lot code
- FR490902
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99607
- Recall number
- Z-3035-2026
- Quantity recalled
- 335 units
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
