Reported Oct 30, 2024 · Ongoing

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound…

B-K Medical A/S

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B-K Medical A/S · Mileparken 34 · Herlev, N/A · N/A

Is this the product you have?

    • bk3000
    • model #2300-11
    • bk3500
    • model #2300-41
    • bk5000
    • model #2300-61
    • and bkActive 2300
    • model #2300-66
    • ultrasound system with battery option
Lot codes and dates
  • All serial numbers, GTIN 05704916000264.
Amount recalled
1648 devices

Where it was sold

  • Nationwide

Why it was recalled

The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.