FDA recall, , Moderate risk
BD Alaris Pump Module Model 8100
The BD Alaris Pump Module may have a date and time issue causing connectivity problems with hospital networks.
Summary by Recall Canary from the FDA notice
What happened
CareFusion 303, Inc. of San Diego, California is recalling the BD Alaris Pump Module model 8100 with UDI-DI code 10885403810046, part of the BD Alaris System with Guardrails Suite MX, a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients.
The recall is due to a number of modules flashed with a date and time associated with the daylight savings time 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.
The company began the recall on November 6, 2025, and it was added to the FDA's Enforcement Report on January 29, 2026.
The recall involves 189 devices distributed nationwide in the states of Arizona, Indiana, Ohio, and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX
- UDI-DI
- 10885403810046
- 17377484
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Recall details
- Company began the recall
- Company
- CareFusion 303, Inc.San Diego, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97871
- Recall number
- Z-1217-2026
- Quantity recalled
- 189 devices
All recalls from CareFusion 303, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
