BD Alaris System Recall - TLS Labeling Security Issue
Summary
FDA issued Class II recall Z-1645-2026 for BD Alaris System with Guardrails Suite MX with Point of Care Unit manufactured by CareFusion 303, Inc. The recall addresses missing product labeling specifying which TLS version must be enabled on hospital networks for secure Wi-Fi communication. Affected devices were distributed nationwide in the U.S. across multiple states.
What changed
CareFusion 303, Inc. initiated a Class II medical device recall (Z-1645-2026) for BD Alaris Systems due to inadequate labeling that fails to specify required TLS versions for secure Wi-Fi communication between Point of Care Units and hospital networks. The security vulnerability affects the entire device system used for medication administration and patient monitoring. Healthcare facilities must identify affected units, verify TLS network configurations, and contact the manufacturer for corrected labeling to ensure proper security protocols are implemented.
Hospital IT departments and biomedical engineering teams should immediately audit their Alaris device inventory against the affected product codes and confirm their network TLS configurations align with security best practices. While no specific compliance deadline is stated, recalls require timely response. The absence of TLS version specifications in product documentation creates potential liability for healthcare organizations if security incidents occur using these devices.
What to do next
- Audit Alaris System inventory to identify affected Point of Care Units
- Verify hospital network TLS configurations are enabled for secure Wi-Fi communication
- Contact CareFusion for corrected labeling and guidance on required TLS version specifications
Source document (simplified)
CareFusion 303, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1645-2026 · 20260401 · Ongoing
Product
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
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, ...
Source: openFDA Enforcement API
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Healthcare alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Device Recalls Class II publishes new changes.