Recall Z-1645-2026
CareFusion 303, Inc. · initiated February 11, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Codes / lots: Catalog Number: 8015 UDI-DI codes: 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023 10885403519215 10885403519284 10885403519291 10885403801518 10885403801532 10885403801549 Serial Numbers: 12360968 12360983 12360985 12360986 12360987 12360988 12360989 12360990 12360991 12360992 12360993 12360994 12360995 12360996 12360997 12360998 12360999 12361000 12361001 12361002 12361003 12361004 12361005 12361006 12361008 12361010 12361013 12361017 12361018 12361019 12361020 12361021 12361022 12361024 12361026 12361027 12361028 12361029 12361030 12361031 12383470 12383471 12383472 12386884 12386885 12388269 12389653 12389660 12389680 12389683 12389691 12389698 12389715 12389727 12389730 12389734 12389738 12389740 12389741 12390061 12390104 12390107 12390118 12390133 12390155 12390184 12390187 12390199 12390219 12390236 12390239 12390257 12390258 12390271 12390274 12390290 12390293 12390300 12390301 12390302 12390558 12390560 12390578 12390597 12390603 12390619 12390620 12390634 12390635 12390654 12390662 12390666 12390670 12390678 12390701 12390721 12390722 12390729 12390731 12390736 12390738 12393833 12393834 12393836…
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
FDA-determined cause: Under Investigation by firm
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
Details
- Recall number
- Z-1645-2026
- Initiated
- February 11, 2026
- Posted by FDA
- March 26, 2026
- Product code
- FRN – Pump, Infusion
- Quantity
- 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, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S. (foreign) to countries of: Australia, Belgium, Bahrain, Botswana, Canada, China, Cuba, Germany, India, Israel, Italy…
- Recalling firm
- CareFusion 303, Inc., San Diego, CA