Recall Z-0584-2025— Becton Dickinson & Co.

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007. Reason: 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..

Recalling firm
Becton Dickinson & Co.
Classification
Class II
Status
Ongoing
Initiated
2024-10-31
Firm location
Sparks, MD, United States

Product description

BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.