Changeflow GovPing Healthcare BD Alaris System Recall - TLS Labeling Security...
Priority review Enforcement Removed Final

BD Alaris System Recall - TLS Labeling Security Issue

Favicon for changeflow.com FDA: Device Recalls Class II
Filed April 1st, 2026
Detected April 7th, 2026
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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

  1. Audit Alaris System inventory to identify affected Point of Care Units
  2. Verify hospital network TLS configurations are enabled for secure Wi-Fi communication
  3. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1645-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers 6221 Hospitals & Health Systems
Activity scope
Medical Device Recall
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Cybersecurity Healthcare

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