HomeMedical Device recalls
Medium severity

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateFebruary 11, 2026
ReportedApril 01, 2026
Recalling firmCareFusion 303, Inc.
Country / regionUnited States CA

Hazard

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

Affected products

Related recalls

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS- · May 20, 2026QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. · May 20, 2026Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: · May 20, 2026Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 · May 20, 2026BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER · May 20, 2026