Z-2017-2025Class II

Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis...

Name: Z-2017-2025 Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis...
Creator: CareFusion 303, Inc.
Published: 2025-05-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-05-08 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of 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... on 2025-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2017-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-08
Posted: 2025-06-24
Recalling firm: CareFusion 303, Inc
Product: 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]
Product code: BRY Cabinet, Table And Tray, Anesthesia
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 5/8/2025, correction notices were mailed and emailed to Customers informing them of the following: Firm has temporarily configured impacted devices to "disabled" mode so the device will not automatically apply validated patches intended to address security vulnerabilities or performance issues. Device keys can be used to manually access unavailable drawers and must be readily available and retrievable to constitute risk mitigation; medications can also be obtained from other unaffected dispensing devices or pharmacy. The Pyxis Anesthesia Station unlocks non-secure drawers upon user login, providing immediate access to medications. Non-secure drawers remain unlocked while the user is logged in. User guides include instructions on how to manually access medications in an emergency: BD Pyxis MedStation ES user guide DME 10000430667 version 00 (page 120), BD Pyxis Anesthesia Station ES user guide DME 10000430730 version 00 (page 84). Other potential mitigations: -Healthcare facility system administrators can grant permission to add temporary patients to select staff per user guide DME 10000430667 version 00 (page 25). -Critical override or temporary Non-RX mode can be configured for impacted profile devices per user guide DME 10000430667 version 00 (pages 74-75). -Refill reports can be generated at the device to identify items requiring replenishment if inventory information is not communicated to the server. Share the recall letter with all network facilities and post recall letter on/near affected products. Complete and return response form: [email protected] Firm will coordinate with customers to obtain a schedule to implement "Managed Mode". Firm contacts: North American Regional Complaint Center: 1-844-823-5433, [email protected]; BD Remediation Support: 1-866-583-8783; BD Technical Support: 1-800-727-6102 On 12/2/2025 updated correction notices including additional affected devices were mailed/emailed to customers
Quantity in commerce: 6,332
Distribution: 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.
Product codes and lots: 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]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2017-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2017-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-24

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)