FDA DevicesClass II
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Published: April 1, 2026Recall ID: Z-1645-2026Category: devicesCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 98250 |
| Address 1 | 10020 Pacific Mesa Blvd |
| Code info | 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 ... [TRUNCATED] |
| Postal code | 92121-4386 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 1,025,567 |
| 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260211 |
| Initial firm notification | Letter |
| Center classification date | 20260326 |
Overview
- Recalling FirmCareFusion 303, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.