Z-1631-2026Class II

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog...

Name: Z-1631-2026 Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog...
Creator: Koven Technology, Inc.
Published: 2026-03-04
License: https://open.fda.gov/license/

Koven Technology, Inc. / initiated 2026-03-04 / Open, Classified / root cause: labeling and UDI

FDA source

Koven Technology, Inc. began a recall of 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... on 2026-03-04. FDA classified it as Class II and gives the reason as "Product labeling includes a fetal indication for use that is not cleared under its 510(k)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1631-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-04
Posted: 2026-03-24
Recalling firm: Koven Technology, Inc.
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.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On March 4, 2026, firm began notifying customers via first-class mail. Customers were informed they may still use the BiDop 3 device for vascular applications, but that the device is not cleared for fetal usage. Koven Technology, Inc. will provide a replacement operation manual for devices that are being amended to remove fetal use indications.
Quantity in commerce: 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.
Product codes and lots: Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1631-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1631-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24

Product code DPW

K954397Class IIBidirectional Doppler W/waveform DisplayKoven Technology, Inc. / cleared 1996-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)