Class II U.S. Food and Drug Administration

Koven Technology, Inc. Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler recall: Product labeling includes a fetal indication for use that is not cleared

Recall published 7 months ago

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1631-2026
Published
April 1, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Koven Technology, Inc.
Product type
Medical devices
Units affected
34
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
UPC codes
00894912002043, 00894912002326

Products covered by this recall

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.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00894912002043
  • 00894912002326

Model or item number

On the rating label, the box or the instruction sheet.

  • ES-100V3

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Koven Technology, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Koven Technology, Inc. — 477 N Lindbergh Blvd Ste 220, Saint Louis, MO, 63141-7856

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Koven Technology, Inc. medical devices recalled?

Product labeling includes a fetal indication for use that is not cleared under its 510(k). Product labeling includes a fetal indication for use that is not cleared under its 510(k).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00894912002043, 00894912002326; model number ES-100V3. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls