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Koven Technology, Inc. affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications
Source: FDA | Recall date: 04/01/2026
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Affected product: affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Brand: koven technology, inc.
Hazard: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Official identifiers
- FDA recall number
- Z-1631-2026
- FDA event number
- 98556
Don't want to manually check every recall?
Track your baby products and get automatic recall alerts when something may affect your family.
Learn more about the baby product recall tracker, automatic email item adding, or recall monitoring plans.