Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-
FDA device recall Z-1631-2026 · posted 2026-03-24 · Open, Classified
Recall details
- Recalling firm
- Koven Technology, Inc.
- Reason for recall
- Product labeling includes a fetal indication for use that is not cleared under its 510(k).
- Action taken
- On March 4, 2026, firm began notifying customers via first-class mail. Customers were informed they may still use the BiDop 3 device for vascular applications, but that the device is not cleared for fetal usage. Koven Technology, Inc. will provide a replacement operation manual for devices that are being amended to remove fetal use indications.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DPW
- Quantity affected
- 34
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
- Date initiated
- 2026-03-04
- Date posted
- 2026-03-24
- Location
- Saint Louis, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY (K954397) | Koven Technology, Inc. | 1996-03-29 |