FDASeptember 23, 2025device

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

becton dickinsonbectonbecton dickinson

UPCs

0038290441916500382904419271

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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