# FDA recall Z-0435-2026 > **B-K Medical A/S** · Class II · device recall initiated 2025-10-09. ## Product 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 Doppler, Ultrasonic ## 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. ## Distribution 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. ## Key facts - **Recall number:** Z-0435-2026 - **Recalling firm:** B-K Medical A/S - **Classification:** Class II - **Product type:** device - **Status:** Ongoing - **Initiation date:** 2025-10-09 - **Report date:** 2025-11-12 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Herlev, N/A, Denmark ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0435-2026 ## Citation > AI Analytics. FDA recall Z-0435-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0435-2026. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*