CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Recall date

February 11, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1645-2026

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

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…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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