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FDA-Device2026-02-04Class IIPROCESSING DEFECT

BD Alaris Pump Module 8100 recalled for network connectivity issue

CareFusion
OTHERNationwide distribution

Check your BD Alaris Pump Module 8100

Some BD Alaris Pump Module 8100 infusion pumps have a software date/time issue related to daylight saving time that may prevent them from connecting to hospital networks. This affects only the network connectivity function; the pump's ability to deliver medication is not impacted. The issue involves 189 devices distributed in Arizona, Indiana, Ohio, and Virginia.

  • If your hospital operates a BD Alaris System with a Pump Module 8100, check whether your device's serial number is on the recall list (provided by BD/CareFusion).
  • Contact BD customer support or your hospital's biomedical/clinical engineering department for instructions on software updates or replacement.
  • Do not remove the pump from service; continue normal operation while awaiting guidance.
Hazard

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network

Sold states
U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.
Affected count
189 devices
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2026

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