CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

BK Medical ApS Ultrasound System Scanner bk2300 recalled

B-K Medical is recalling BK Medical ApS Ultrasound System Scanner bk2300, distributed in Florida, Massachusetts, Texas. The recall was initiated on 28 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Quantity recalled6

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2325-2016
FDA event ID: 74691
Recalling firm: B-K Medical, Herlev
Classification: Class II
Status: Terminated
Recall initiated: 28 Jun 2016
FDA classified: 3 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

28 Jun 2016	Recall initiated by company
3 Aug 2016	Classified by FDA	+36 days
10 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

Where it was distributed

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

Florida Massachusetts Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Where was it sold?

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from B-K Medical

All 9

Reported	Class	Recall	Company	Reason	Where
12 Nov 2025Device	CLASS II	bk3500 Ultrasound System w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS II	bk3000 Ultrasound System w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS II	1202 Flex Focus Ultrasound System, cart recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS II	UUltrasound System 2300, bkActiv w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS II	bk5000 Ultrasound System w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide