Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

Recall date
October 31, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0590-2025
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chil…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

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