BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

FDA device recall Z-1645-2026 · posted 2026-03-26 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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

Action taken

On 02/11/2026, the firm sent via US Postal mail, an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter to customers informing them that labeling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the Alaris and BD Alaris Point-of-Care Unit (PCU) when using enterprise-level Wi-Fi security. Without clear labeling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential System Error. Customers/clinicians are instructed to: 1. Ensure the PCU is connected to the hospital network by viewing the wireless indicator icon on the front of the PCU. If the icon is illuminated or blinking, the PCU is connected. If it is not illuminated, the PCU is not connected. 2. If icon is not illuminated, follow established hospital protocols for wireless network downtime. 3. If a network connectivity failure persists, System Error may occur on the PCU. This error is indicated by a high priority alarm and red blinking arrow above the SYSTEM ON button. The customer must power down the PCU, then power on again. Any infusion that was ongoing at the time of System Error must be reprogrammed. 4. If using enterprise-level network security, customers/IT Security should be aware of which versions of TLS must be enabled to ensure connectivity. Refer to Appendix A for additional network administration guidance and compatibility. 5. Disseminate and post this notice within their facility to ensure that all concerned personnel, including IT and network connectivity owners or administrators, are notified and aware of this issue. For Questions/Assistance - contact the Recall Support Center at: Phone: 1-888-562-6018 Phone Hours: 7:00am to 4:00pm PT, Monday- Friday Email: SupportCenter@bd.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FRN

Quantity affected

1,025,567

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, O

Date initiated

2026-02-11

Date posted

2026-03-26

Location

San Diego, CA

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