Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler — Class II medical device recall Z-1631-2026
Ongoing recall by Koven Technology, Inc., reported 2026-04-01, distributed nationwide. Product labeling includes a fetal indication for use that is not cleared under its 510(k).
| Recall number | Z-1631-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Koven Technology, Inc., Saint Louis, MO, United States |
| Recall initiated | 2026-03-04 |
| Classified | 2026-03-24 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 34 |
| Reason classes | labeling, unapproved product |
| UPC / GTIN / UDI-DI | 00894912002043, 00894912002326 |
| Model numbers | ES-100V3 |
Product
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Reason for recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1631-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.