Medical DeviceApr 1, 2026
BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe recall — FDA Z-1631-2026
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Class IIFDA: OngoingKoven Technology, Inc.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Koven Technology, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.