Medical Device: BD MAX System Service Credential Breach Poses Unauthorized Access Risk
An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall where an unauthorized actor has already accessed service credentials. While no illnesses or injuries have been reported, the potential impact on system integrity, data confidentiality, and data availability in a medical diagnostic system poses a significant risk of harm. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported.'
Plain-English summary
Becton Dickinson & Co. recalled 2,537 units of the BD MAX System, model 441916, after an unauthorized actor accessed product service credentials used by some BD technical support teams. These automated diagnostic systems were distributed worldwide, including 876 units in the United States and 1,661 units internationally.
An unauthorized actor gained access to the product service credentials used by BD technical support teams. Until these 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.
The recalled product
- Product
- BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
- Manufacturer
- Becton Dickinson & Co.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog No: 441916
- UDI-DI: 00382904419165
- Serial Numbers: CT1777
- CT1168
- CT1902
- CT2015
- CT1939
- CT2084
- CT2113
- CT2216
- CT2191
- CT1972
- CT1175
- CT2157
- CT2698
- CT3324
- CT1174
- CT0849
- CT1186
- CM0122
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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