CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report

bk3500 Ultrasound System w/battery recalled by B-K Medical A/S

B-K Medical is recalling bk3500 Ultrasound System w/battery, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 05704916000264 and pending, Serial Numbers: 5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 5009726, 5009021, 5008627, 5008542, 5008280, 5008994, 5007594, 5008019, 5009344, 5009000, 5009001, 5009002, 5009339, 5009340, 5009722, 5013052, 5013067, 5008617, 5007733, 5009361, 5008995, 5009357, 5008012, 5009732, 5006923, 5007592, 5009019, 5009723, 5009729, 5009003, 5009005, 5008271, 5009730, 5007422, 5009747, 5007424, 5008265, 5008534, 5009012, 5009740, 5008541, 5006928, 5009737, 5009347, 5009348, 5009349, 5009363, 5009720, 5008625, 5009733, 5009360, 5009013, 5009014, 5007429, 5007742, 5009719, 5013351, 5009011, 5009017, 5009727, 5013069, 5008262, 5009020, 5007850, 5009335, 5009336, 5007609, 5009004, 5007608, 5007857, 5009338, 5009725, 5009351, 5009724, 5008147, 5009350, 5009352, 5008623, 5009738, 5008996, 5008274, 5013610, 5009341, 5013591, 5009742, 5008551, 5009741, 5008053, 5008269, 5008018, 5008267, 5009010, 5009739, 5013423, 5007426, 5007611, 5007855, 5009745, 5009734, 5007738, 5008533, 5008014, 5008270, 5008536, 5009007, 5008545, 5008281, 5009342, 5009343, 5009728, 5009735, 5009736, 5009746, 5013319, 5013325, 5013586, 5008626.

Quantity recalled124 units

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-0439-2026
FDA event ID: 97830
Recalling firm: B-K Medical, Herlev, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 9 Oct 2025
FDA classified: 6 Nov 2025
Reported: 12 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

9 Oct 2025	Recall initiated by company
6 Nov 2025	Classified by FDA	+28 days
12 Nov 2025	Published in enforcement report	+6 days

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

Reason for recall

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

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

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

Where it was distributed

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 05704916000264 and pending, Serial Numbers: 5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 5009726, 5009021, 5008627, 5008542, 5008280, 5008994, 5007594, 5008019, 5009344, 5009000, 5009001, 5009002, 5009339, 5009340, 5009722, 5013052, 5013067, 5008617, 5007733, 5009361, 5008995, 5009357, 5008012, 5009732, 5006923, 5007592, 5009019, 5009723, 5009729, 5009003, 5009005, 5008271, 5009730, 5007422, 5009747, 5007424, 5008265, 5008534, 5009012, 5009740, 5008541, 5006928, 5009737, 5009347, 5009348, 5009349, 5009363, 5009720, 5008625, 5009733, 5009360, 5009013, 5009014, 5007429, 5007742, 5009719, 5013351, 5009011, 5009017, 5009727, 5013069, 5008262, 5009020, 5007850, 5009335, 5009336, 5007609, 5009004, 5007608, 5007857, 5009338, 5009725, 5009351, 5009724, 5008147, 5009350, 5009352, 5008623, 5009738, 5008996, 5008274, 5013610, 5009341, 5013591, 5009742, 5008551, 5009741, 5008053, 5008269, 5008018, 5008267, 5009010, 5009739, 5013423, 5007426, 5007611, 5007855, 5009745, 5009734, 5007738, 5008533, 5008014, 5008270, 5008536, 5009007, 5008545, 5008281, 5009342, 5009343, 5009728, 5009735, 5009736, 5009746, 5013319, 5013325, 5013586, 5008626.

Where was it sold?

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.

Other products in this recall event

5 other products · FDA event 97830

This product is part of a recall event; the main page for the event is Ultrasound System 1300, bkSpecto w/battery recalled by B-K Medical A/S.

Reported	Class	Recall	Company	Reason	Where
12 Nov 2025	CLASS II	Ultrasound System 1300, bkSpecto w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025	CLASS II	bk5000 Ultrasound System w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025	CLASS II	UUltrasound System 2300, bkActiv w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025	CLASS II	1202 Flex Focus Ultrasound System, cart recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
12 Nov 2025	CLASS II	bk3000 Ultrasound System w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide

More recalls from B-K Medical

All 9

Reported	Class	Recall	Company	Reason	Where
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
12 Nov 2025Device	CLASS II	Ultrasound System 1300, bkSpecto w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide

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