ClearanceBrief
Recall Z-1028-2026 ยท BRY Cabinet, Table And Tray, Anesthesia

CareFusion 303, Inc.

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-

DateJan 8, 2026 (initiated Dec 3, 2025)
StatusOpen, Classified
ReasonDue a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Root causeUnder Investigation by firm
ActionOn 12/03/2025, the firm sent U.S. Postal and email an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that BD received customer complaints of BD Pyxis" equipment not receiving timely updates of patient, medication, or related information from enterprise systems. This resulted in new patient and/or order information to be delayed from displaying on connected Pyxis equipment, and a delay in any changes to current patient orders being applied to the patient profile within Pyxis. Customers are instructed to: 1.Refer to the BD Pyxis" ES User Guides warning: Instruct end user
Quantity2,079 systems
DistributionWorldwide - U.S. Nationwide distribution including in the states of AK,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, 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. The countries of B
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.