Food, drugs, devices › CareFusion 303, Inc.
Device recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
FDA enforcement event 98250 is a device recall by CareFusion 303, Inc. of San Diego, CA, initiated 11 Feb 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. CareFusion 303, Inc. has 99 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CareFusion 303, Inc., San Diego, CA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1645-2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | 1,025,567 | Class II | Ongoing | 1 Apr 2026 |
Context
Other enforcement events for CareFusion 303, Inc.
All 99 events for CareFusion 303, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.