1202 Flex Focus Ultrasound System — Class II medical device recall Z-0435-2026
Ongoing recall by B-K Medical A/S, reported 2025-11-12, distributed nationwide. GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not a
| Recall number | Z-0435-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B-K Medical A/S, Herlev, N/A, Denmark |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-06 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, LV, MA, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TW, UA, ZA |
| Quantity | 4,426 units |
| UPC / GTIN / UDI-DI | 05704916001056, 05704916001087 |
| Serial numbers | 1893118, 1893197, 1895793, 1900915, 1900917, 1900918, 1900922, 1900975, 1901001, 1901888, 1902575, 1902581, 1902606, 1903592, 1903593, 1904324, 1904364, 1904366, 1904368, 1904370, 1904372, 1905149, 1905993, 1906001, 1906005 and 475 more |
| Model numbers | UA1214, UA1814 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0435-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.