BD Pyxis Product Name / UDI-DI code / Catalog No — Class II medical device recall Z-2477-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-09-03, distributed nationwide. Antivirus software was not consistently installed on impacted devices during the implementation process.
| Recall number | Z-2477-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2025-05-08 |
| Classified | 2025-08-28 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BH, BM, BR, BS, CA, CH, DE, EG, FI, FR, GB, GR, HK, ID, IE, IN, IT, JO, LB, MA, MX, MY, NZ, OM, QA, SA, SG, TH, TW |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403477836, 10885403512520, 10885403512568, 10885403512605, 10885403512629, 10885403512667, 10885403512674, 10885403518348, 10885403520341 |
| NDC | 00877-2778-42, 01478-5972-41, 01678-3395-47, 01880-1191-44, 02015-9361-41, 03547-0862-04, 03625-0216-44, 04062-3961-49, 04313-2816-43, 05040-1206-44, 05246-1403-04, 06628-7085-45, 07178-0706-43, 07198-3724-47, 07413-8607-49, 07759-6921-47, 07933-5884-45, 07945-4059-47, 08528-2252-47, 09292-8309-48, 09577-9869-44, 09761-3906-48, 10584-9454-04, 18252-9002-48, 18433-4278-04 and 19 more |
| Model numbers | 2RADRXSM, 3S1, 3SW, 4000, 4A.AAMC.ORG, 4MK, 6A.AAMC.ORG, 9A0, A-IR2, ACH-V11-PYXTEST, ACTXCLTPX2, AEPLAB2, AHSCPYX-ANES01, AHSCPYX-ANES02, AHSCPYX-ANES03, AHSCPYX-ANES04, AHSCPYX-ANES05, AHSCPYX-ANES06, AHSCPYX-ANES07, AHSCPYX-ANES08, AHSCPYX-ANES09, AHSCPYX-ANES10, AHSCPYX-ANES11, AHSCPYX-ANES12, AHSCPYX-ANES13 and 336 more |
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.
Reason for recall
Antivirus software was not consistently installed on impacted devices during the implementation process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2477-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.