Recall Z-1645-2026— CareFusion 303, Inc.
Class II · Ongoing
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2026-02-11. It names 6 FDA 510(k) clearances: K211218, K133532, K072105 and 3 more. Product: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit. Reason: 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.
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-11
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
6 on FDA's record- K211218 — BD Alaris System with Guardrails Suite MX v12.1.2
- K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX
- K072105 — ALARIS SYSTEM WITH MMS, MODEL 8XXX
- K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001
- K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
- K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.