Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Recommended action
What to do
34
Product description
Product labeling includes a fetal indication for use that is not cleared under its 510(k).