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

Recall Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

U.S. FDA — Device Enforcement · United States · 2026-02-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1645-2026
Date of alert
2026-02-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10885403210747
Reported risk: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.