Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0590-2025 — BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

U.S. FDA — Device Enforcement · United States · 2024-10-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0590-2025
Date of alert
2024-10-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Becton Dickinson & Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00382904419165
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.