Class II — Koven Technology, Inc.
| Recalling firm | KOVEN TECHNOLOGY, INC. |
|---|---|
| Registered facility | KOVEN TECHNOLOGY, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |
| 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. |
| Quantity | 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. |
| Initiated | 2026-03-04 |
| Classified | 2026-03-24 |
| Recall number | Z-1631-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Koven Technology, Inc. (Z-1631-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98556/
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