FDA Medical devices recall ·

BD Pyxis Product Name / UDI-DI code recall

Recall number
Z-2477-2025
Date
(initiated May 8, 2025)
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
8353 devices (6738 U.S. and 1615 O.U.S.)
Hazard tags
Software
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

BD Pyxis Product Name / UDI-DI code / Catalog No. 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 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System 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, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Why was it recalled?

Antivirus software was not consistently installed on impacted devices during the implementation process.

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

BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 Atlas Key / Computer Name: DF36449C-9896-4A27-BC18-481981535F84 OR2 993BA58F-B5FB-49E8-AE94-BC81E0A93C2A ER-PED FF9AD713-320E-4317-94C0-1A7F57F1AA63 K3 25845A1C-20A3-44BA-8D78-9C9DC001F5B8 PYXH5SASC 2BFA94A6-6192-4ACA-B495-06BA07DC2D73 ESC-WARD1 38404D6B-8356-476A-970F-E4F9CE5731DB WC A9EF86BC-6DF5-4F7F-AE54-6F51773D343E THEATRE12W 1B194D06-1F1A-4930-AA42-57BBDF1E72EE OAKTON B7F75FB9-7480-4C2F-8E91-66D5AF2C0607 MEDSURG 390D8BC7-36E3-4D8D-8CB6-E9360C197DE5 W15 D83C62B5-8D53-4A6B-85AD-E0119DF3E186 THEATRE6 63605AE3-DC21-45BB-A882-F40E22EF811E MEDSHIP 1D2BA923-E0B0-4DE4-BFDB-69247B773273 ED-1 4D0B213F-D42B-4829-9431-1C4D482B1D67 THEATRE 3482ADD7-D610-4FD7-B561-2CC85D4028D4 4K102713S1 214209FD-6AD2-48CE-A15F-8252209D60EF HAMPDENFC_pyx 0B8D0E14-7E8E-4AE7-B492-726887F4411C W5-AUX CF5045AE-86EE-4698-ACEA-3581C9EC7CD1 THEATRE7 92F5A739-E0CA-4C9B-AD3D-27CF3921F944 ACARE 00AAEB97-9E1B-4738-B7EF-93A1EA43A46C LD 4A431A7F-5476-4EA3-899B-71CBDD82799E ADU-DIAG FC072559-E041-41F4-8879-40C03F076484 PXJAXMHC 95A507B9-D859-4622-916B-1C41935BFC55 MEDSHIP 791A5DA7-CC98-4061-8FE5-6065E0CB3A1F PXJAXPROC1 C5EA0AEC-0917-4350-A0C0-5C926F04CF2E MS_SIM 693763A3-0D4A-4CFC-8037-9972131A8924 MS_SKILL 1204B120-1B79-4C7B-824E-ED0A35A07F4D ADU-ASSESS 7FAF82BF-8C1E-4CB3-95A8-9427E78AD973 ECCW-RESUS D50DF9EB-62BB-4FBA-890B-A4245C1C770B EL_D430 88F6239C-2EE3-486A-A29E-CEA9D1F7F6C8 W8 376EFDC5-52C7-42A1-8AC8-A

Distribution

Worldwide - 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, 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. The countries of United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Bermuda, Brazil, Bahamas, Canada, Switzerland, Germany, Egypt, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Lebanon, Morocco, Mexico, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, Thailand, Greece, Oman, and Taiwan.

States: Alaska 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-2477-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.