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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96585

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 08, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CareFusion 303, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

Z-2017-2025
Recall number
Z-2017-2025
Initiated
May 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
6,332

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
error preventing user access to the dispensing software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.

Code information

Each customer was provided a unique list of their affected devices that included computer names and atlas keys. Distributed: April 14, 2014 - March 21, 2025 REF or Name [UDI-DI]: Supply Server [N/A], CCE Enterprise SW Site License (2-5) [N/A], 806 [N/A], 303 [10885403512629], 352 [10885403512674], 327 [10885403477836], 323 [10885403512667], 317 [N/A], 139698-01 [N/A], 136607-01 [N/A], 132-53-02 [N/A], 132-53-01 [N/A], 132-52-02 [N/A], 132-52-01[N/A] , 1156-00 [N/A], 1132-00 [N/A], 1127-0 [N/A], 1128-00 [N/A], 1123-00 [N/A], 1116-00 [N/A], 1115-00 [10885403518348, 10885403520341], 1101-00 [N/A], 111-221 [10885403512520], 111-194 [N/A], 107-245-01 [N/A], 347[N/A], 107-252-01 [N/A], 111-191 [N/A], 111-198 [N/A], 111-202-01 [N/A], 111-206-01 [N/A], 111-215 [10885403512520], 111-216 [10885403512520], 111-219 [10885403512520], 138566-01 [N/A]

Distribution pattern

Worldwide - US Nationwide distribution including in the states of PR, DE, GU, MO, IA, IL, CA, MD, MA, VA, PA, NY, WA, NJ, AZ, CO, OH, FL, WI, TX, CT, LA, MI, WY, MN, AR, KY, OR, NM, TN, NC, SC, IN, VT, KS, AL, GA, WV, NV, ID, DC, MS, NE, HI, OK, UT, ND, MT, NH, SD, ME, RI, AK, MP and the countries of SA, CA, NZ , CH, FR, IT, BE, AU, BH, QA, AE, GB, EG, AR, JO, DE, BM, TH, LB, BR, IE, FI, MX, TW, ID, SG, BS, IN, MA, GF, ES, HK.