BD BACTEC FX — Class II medical device recall Z-0593-2025
Ongoing recall by Becton Dickinson & Co., reported 2024-12-11, distributed nationwide. BD confirmed that product service credentials used by some BD technical support teams to access certain BD pro
| Recall number | Z-0593-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-10-31 |
| Classified | 2024-12-03 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HN, HR, HT, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00382904413859 |
| Serial numbers | FB1310, FB1576, FT0007, FT0014, FT0019, FT0021, FT0024, FT0025, FT0026, FT0029, FT0030, FT0034, FT0036, FT0043, FT0050, FT0055, FT0058, FT0059, FT0070, FT0071, FT0075, FT0081, FT0082, FT0084, FT0086 and 475 more |
| Model numbers | 441385 |
Product
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Reason for recall
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
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-0593-2025. 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.