Drug & Device Safety Atlas

FDA recall record · openFDA

B-K Medical A/S

8 FDA recalls on record (2023–2025) — 8 device. 8 still ongoing.

0
Class I (most serious)
8
Class II
0
Class III
8
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately 6
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential fo 1
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. 1

Recalls

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic Class II 2025-10-09 bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic Class II 2025-10-09 UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic Class II 2025-10-09 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focu Class II 2025-10-09 bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic Class II 2025-10-09 bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic Class II 2025-10-09 bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy Class II 2024-09-04 bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. Class II 2023-11-30

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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