BD MAX System (BD) – credential breach (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
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).
Products Sold
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).
Becton Dickinson & Co. is recalling BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MA due to Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Beckton, Dickenson and Company notified consignees on about 09/23/2025 via mailed letter and email. This updated letter serves as a supplement to the original field action communication, dated 10/31/2024. It is intended to clarify that the previously described issue remains unchanged; however, the scope of the impacted product SKUs has been expanded. The update specifically documents additional SKUs including refurbished product codes that were not included in the original communication. Consignees were instructed to follow outlined best practices for maintaining strong security measures to protect hospital networks and medical devices, read and understand the recall notification, provide the letter to all applicable personnel or customers if further distributed, and complete and return the Customer Response Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026