FDA Medical devices recall ·
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall
- Recall number
- Z-1645-2026
- Date
- (initiated February 11, 2026)
- Company / brand
- CareFusion 303, Inc.
10020 Pacific Mesa Blvd, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,025,567
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 12393843 12393870 12393916 12393922 12393929 12393953 12393954 12394011 12394012 12394013 12394015 12394040 12394066 12394105 12394106 12394126 12394171 12394179 12394209 12394219 12394222 12394283 12394284 12394290 12394293 12394298 12394301 12394596 12394619 12394643 12394646 12394659 12394672 123946
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, Japan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1645-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.