Lower riskMedical device recall · FDA · Published February 18, 2025
BD Alaris Systems Manager Software Recall: Outdated Programming Requests Risk
CareFusion recalls BD Alaris Systems Manager software versions 12.5.1 and 12.5.2 due to potential outdated automated programming requests for infusion units. Affected units may require updates to prevent safety issues.
“BD Alaris Systems Manager Software Recall: Outdated Programming Requests Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52806-bd-alaris-systems-manager-software-recall-outdated-programming-requests-risk. Based on FDA recall #Z-1304-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2025%22&limit=1).
The FDA announced on Feb. 18, 2025, that CareFusion 303, Inc. is recalling BD Alaris Systems Manager REF 9601 Infusion Safety Management Software due to a software issue that may result in outdated automated programming requests being sent to progressive care units.
According to the FDA, a software issue may result in outdated automated programming requests being sent to the progressive care unit. The recall is classified as Class I.
Context
GovInfoNow's records show CareFusion 303, Inc. has had 64 other recalls since 2017-06-12. Other recent recalls of similar products include Fresenius Medical Care 5008X CAREsystem Recall (2025-10-25), Elekta MOSAIQ Oncology System Software Recall (2026-05-21), and GE Medical Systems Portrait Compute V1.2 Software Recall (2026-07-20).
How to tell if you have this one
Check if your software version is 12.5.1, 12.5.2, or any prior versions listed (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3). The unique device identifiers (UDIs) 10885403960123, 10885403519666, and 10885403960116 are also associated with this recall.
Brand
BD Alaris
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
Recall number
Product, codes & lots
Quantity
Z-1304-2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software; Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)
Identify your software version by checking the device settings or documentation. Versions 12.5.1, 12.5.2, or prior versions listed (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) are affected.
Update Software
Contact CareFusion to get the latest software update to fix the outdated programming issue.
Where it went and when
Where it was distributed
Distributed in 20 states and D.C..
Listed by the agency
Not listed
FDA distribution: “US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is for software versions that may send outdated programming requests, which could lead to incorrect dosing. However, the hazard is not described as causing immediate harm, so it's considered low risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1304-2025 (February 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1304-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.