Koven BiDop 3 Pocket Doppler Fetal Probe Class II Recall Z-1631-2026
Summary
FDA classified a Class II recall of Koven Technology's BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C 2 MHz fetal probe. The device is being recalled because product labeling includes a fetal indication for use that was not cleared under the device's 510(k) premarket notification. The recall affects units distributed nationwide across 16 states including LA, NC, MT, TX, MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, and IN.
What changed
FDA initiated a Class II recall of Koven Technology's BiDop 3 Pocket Doppler (ES-100V3) and BT2M20S8C fetal probe due to labeling that includes a fetal indication for use without proper 510(k) clearance. The recall number is Z-1631-2026 and the action is ongoing. \n\nAffected parties should immediately identify any inventory of the BiDop 3 device and fetal probe, verify current labeling against cleared indications, and contact the firm for corrective action procedures. Healthcare providers using this device should confirm whether their clinical protocols rely on the uncleared fetal indication and adjust accordingly.
What to do next
- Contact Koven Technology for recall details and corrective actions
- Review inventory for affected Koven BiDop 3 devices and fetal probes
- Remove or correct any labeling claiming fetal use that is not 510(k) cleared
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Koven Technology, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1631-2026 · 20260401 · Ongoing
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 Prod...
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.
Source: openFDA Enforcement API
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