--- title: "B-K Medical A/S Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search B-K Medical A/S recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/b-k-medical-a-s/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # B-K Medical A/S recall records **8** reported ongoing 8 records in this archive. Latest source date Oct 9, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Oct 9, 2025 FDA device enforcement ### [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; Syst...](https://isitonrecall.com/recall/fda-device-z-0435-2026-1202-flex-focus-ultrasound-system-cart-models-ua1214-and-ua1814-used-with-flex-focus-200-flex-focus/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0435-2026%22) Oct 9, 2025 FDA device enforcement ### [Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic](https://isitonrecall.com/recall/fda-device-z-0436-2026-ultrasound-system-1300-bkspecto-w-battery-model-no-1300-21-or-1300-s1-system-imaging-pulsed-doppler/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0436-2026%22) Oct 9, 2025 FDA device enforcement ### [UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic](https://isitonrecall.com/recall/fda-device-z-0437-2026-uultrasound-system-2300-bkactiv-w-battery-model-no-2300-11-system-imaging-pulsed-doppler-ultrasonic/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, U...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0437-2026%22) Oct 9, 2025 FDA device enforcement ### [bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic](https://isitonrecall.com/recall/fda-device-z-0438-2026-bk3000-ultrasound-system-w-battery-model-no-2300-66-system-imaging-pulsed-doppler-ultrasonic/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0438-2026%22) Oct 9, 2025 FDA device enforcement ### [bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic](https://isitonrecall.com/recall/fda-device-z-0439-2026-bk3500-ultrasound-system-w-battery-model-no-2300-41-system-imaging-pulsed-doppler-ultrasonic/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0439-2026%22) Oct 9, 2025 FDA device enforcement ### [bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic](https://isitonrecall.com/recall/fda-device-z-0440-2026-bk5000-ultrasound-system-w-battery-model-no-2300-61-system-imaging-pulsed-doppler-ultrasonic/) 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. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cos... [Official source for bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0440-2026%22) Sep 4, 2024 FDA device enforcement ### [bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.](https://isitonrecall.com/recall/fda-device-z-0136-2025-bk3000-model-2300-11-bk3500-model-2300-41-bk5000-model-2300-61-and-bkactive-2300-model-2300-66-ultra/) The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable. Class II Reported ongoing Distribution: Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croati... [Official source for bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0136-2025%22) Nov 30, 2023 FDA device enforcement ### [bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.](https://isitonrecall.com/recall/fda-device-z-0813-2024-bkactiv-ultrasound-system-2300-model-numbers-2300-56-and-2300-66/) An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID, IL, KS, MA, MD, MI, MO, NC, NE, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, and WV. [Official source for bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0813-2024%22) ## Reasons in these listed records - 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. - The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable. - An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. These examples come from this result page and are not a ranking of every recall reason. ## Checking B-K Medical A/S ### Is there a recall on b-k medical a/s right now? This archive contains 8 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search B-K Medical A/S](https://isitonrecall.com/check/?q=B-K%20Medical%20A%2FS) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)