Official recall notice
FDA DeviceClass IINotable
FDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Recall date
- 2026-04-01
- Brand
- CareFusion 303, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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
Recommended action
What to do
1,025,567
Product description
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