FDA Device recall Z-0238-2026
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609,…
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609,… by Becton Dickinson And, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0238-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-23 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number (Serial Numbers): 44191609, UDI/DI: 00382904419165, (CT0883, CT0636, CT0462, CT0303, CT1217, CT0257, CT0…Catalog Number (Serial Numbers): 44191609, UDI/DI: 00382904419165, (CT0883, CT0636, CT0462, CT0303, CT1217, CT0257, CT0709, CT0786, CT0713, CT0765, CT0668, CT0930, CT0181, CT0564, CM0113, CM0126, CT1319, CT0634, CT1176, CT0910, CM0066, CT0540, CT0138, CM0072, CM0087, CT0534, CT0278, CM0047, CT2365, CT0242, CM0042, CT0558, CT0648, CT0723, CT0855, CT1179, CT0446, CM0125, CT0873, CT0875, CT1369, CM0009, CT0336, CT0879, CT1354, CT0309, CT0739, CT1767, CT1551, CT1320, CT1351), 441927, UDI/DI: 00382904419271, (CR1423A, CR0005, CR0009, CR0003, CT0592, CR0008, CR0941, CR0007, CM0105, CR0705, CR0589). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.