Official recall notice
FDA DeviceClass IINotable
FDA Recall: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Elec
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Product description
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Affected products
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.