Olympus Corporation of the Americas: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & acc
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Recall initiated
- 2026-08-18
- Code info
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Product quantity
- 335 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 99607
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