B-K Medical recalls

B-K Medical has 9 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 12 Nov 2025. 8 are still ongoing. 6 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls9since 2016

Last 12 months6reported

Class I00% of total

Ongoing8latest 12 Nov 2025

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 6 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 9 100%Class III 0 0%

Why b-k medical is recalled

Device Malfunction889%
Other Reasons111%

Product types

Imaging Equipment889%
Heart & Vascular Devices111%

By year

2025667%
2024222%
2016111%

Ongoing b-k medical recalls

8 active

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

All b-k medical recalls, newest first

9 total

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
12 Nov 2025Device	CLASS II	Ultrasound System 1300, bkSpecto w/battery recalled by B-K Medical A/S	B-K Medical	Device Malfunction	Nationwide
30 Oct 2024Device	CLASS II	bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model recalled	B-K Medical	Device Malfunction	Nationwide
31 Jan 2024Device	CLASS II	bkActiv Ultrasound System recalled by B-K Medical A/S	B-K Medical	Other	Nationwide
10 Aug 2016Device	CLASS II	BK Medical ApS Ultrasound System Scanner bk2300 recalled	B-K Medical	Device Malfunction	FL, MA, TX

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.