BiDop 3 Pocket Doppler Recall Issued by FDA
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Koven Technology, Inc. is recalling 34 units of the BiDop 3 Pocket Doppler due to labeling that includes an uncleared fetal indication.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
The recall is due to product labeling that includes a fetal indication for use that is not cleared under its 510(k).
Which Products Are Affected
The affected product is the BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe. Model numbers: ES-100V3 (device) and BT2M20S8C (2 MHz fetal probe). Product quantity: 34 units. Distribution: US Nationwide in the states of LA, NC, MT, TX, MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, and IN. Lot Code: BIDOP 3 #00894912002043 and BT2M20S8C #00894912002326. Official recall number: Z-1631-2026.
What You Should Do
Consumers should contact the recalling firm, Koven Technology, Inc., located at 477 N Lindbergh Blvd Ste 220, Saint Louis, MO 63141-7856, as the firm has initiated notifications via methods such as email, fax, letter, press release, telephone, or visit for further instructions on the recalled product.
Why This Matters
This recall ensures that medical devices are used only for properly cleared indications, helping to maintain patient safety and regulatory compliance.
Source
FDA Recall Number: Z-1631-2026. For more information, visit the FDA website at https://www.fda.gov/.
Original source: FDA Official Notice ↗
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