Medical Device Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
CareFusion 303, Inc. · February 11, 2026
Reason for Recall
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
Distribution
Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP. MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S. (foreign) to countries of: Australia, Belgium, Bahrain, Botswana, Canada, China, Cuba, Germany, India, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
1,025,567
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1645-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.