BD MAX System — Class II medical device recall Z-0238-2026
Ongoing recall by Becton Dickinson & Co., reported 2025-10-29, distributed nationwide. Product service credentials used by some BD technical support teams to access certain BD products were accesse
| Recall number | Z-0238-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2025-09-23 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 62 units |
| UPC / GTIN / UDI-DI | 00382904419165, 00382904419271 |
| Serial numbers | 00382904419165, 00382904419271, 44191609, 441927, CM0009, CM0042, CM0047, CM0066, CM0072, CM0087, CM0105, CM0113, CM0125, CM0126, CR0003, CR0005, CR0007, CR0008, CR0009, CR0705, CR0941, CT0138, CT0181, CT0242, CT0257 and 37 more |
| Model numbers | 00382904419165, 00382904419271, 44191609, 441927, CM0009, CM0042, CM0047, CM0066, CM0072, CM0087, CM0105, CM0113, CM0125, CM0126, CR0003, CR0005, CR0007, CR0008, CR0009, CR0705, CR0941, CT0138, CT0181, CT0242, CT0257 and 37 more |
Product
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Reason for recall
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-0238-2026. 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.