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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
Related Medical Device Recalls
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Product Description
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FDA Recall
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Z-0435-2026 - 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed D... 2 11/06/2025 B-K Medical A/S
Z-0437-2026 - UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
Z-0436-2026 - Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
Z-0438-2026 - bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
Z-0439-2026 - bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
Z-0440-2026 - bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
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