bk3000 — Class II medical device recall Z-0136-2025
Ongoing recall by B-K Medical A/S, reported 2024-10-30, distributed nationwide. The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the po
| Recall number | Z-0136-2025 |
|---|---|
| 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 | 2024-09-04 |
| Classified | 2024-10-18 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CN, CR, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HR, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LU, LV, MA, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RS, SA, SE, SG, SK, TH, TR, UA, ZA |
| Quantity | 1,648 devices |
| UPC / GTIN / UDI-DI | 05704916000264 |
| Model numbers | 2300-11, 2300-41, 2300-61, 2300-66 |
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Reason for recall
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.
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-0136-2025. 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.