CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe recalled
Koven Technology is recalling BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe, distributed nationwide in the US. The recall was initiated on 4 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1631-2026
- FDA event ID
- 98556
- Recalling firm
- Koven Technology, Saint Louis, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2026
- FDA classified
- 24 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 4 Mar 2026 | Recall initiated by company | |
| 24 Mar 2026 | Classified by FDA | +20 days |
| 1 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Nationwide ArizonaColoradoFloridaGeorgiaIllinoisIndianaLouisianaMassachusettsMissouriMontanaNorth CarolinaNew YorkOregonTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Which lots are affected?
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Where was it sold?
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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