Olympus Corporation of the Americas recalls POWERSEAL 5 MM
- Recalling company
- 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
- Reason
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 18, 2026
- Reported
- Sep 2, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Status
- Ongoing
- Quantity
- 335 units
- Lot / codes
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3035-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3035-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.