# FDA recall Z-1631-2026

> **Koven Technology, Inc.** · Class II · device recall initiated 2026-03-04.

## 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).

## Distribution

US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.

## Key facts

- **Recall number:** Z-1631-2026
- **Recalling firm:** Koven Technology, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-04
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1631-2026

## Citation

> AI Analytics. FDA recall Z-1631-2026. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-1631-2026. Source: US FDA. Licensed CC0.

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