POWERSEAL 5 MM recall (Olympus Corporation of the Americas)
Medical deviceClass IIOngoing
Summary: Olympus Corporation of the Americas is recalling POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories. Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
What is being recalled
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Why
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan. (states named: Florida, Kansas)
How to tell if yours is affected
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3035-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 18, 2026 |
| Reported | September 2, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 335 units |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from August 2026