Class II U.S. Food and Drug Administration

CareFusion 303, Inc. BD Pyxis Product Name / UDI-DI code / recall: Antivirus software was not consistently installed on impacted devices during

Recall published 1+ years ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Antivirus software was not consistently installed on impacted devices during the implementation process.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2477-2025
Published
September 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CareFusion 303, Inc.
Product type
Medical devices
Units affected
8353 devices (6738 U.S. and 1615 O.U.S.)
Distribution
Nationwide
Made in
United States
Lot / code info
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-A5BBC6E25142 ECCN-MAIN2 9F6D8D27-A49E-4A48-B54F-6D2F47771B7F PIHA 57AABB22-D178-4675-A0CA-E05079BE5046 TITIRANGI ADB8A48C-B0E4-43C0-8B48-77C91563F575 POHUTAKAWA 704F542B-BB45-4A7F-81CC-FFE15EE38DBF ESC-THEA3 C8E8E1D6-7FFB-4AB8-B4E2-61AB8A69997B W10 4F764301-E411-4DE2-92FC-8B4710167613 ECCW-AC2 5B31DC03-7F76-472D-94AE-85DF772924F7 SCBU-NSH E3E4AF31-FF3C-46B0-AAC2-959CD2D96B31 ECCN-RESUS 1611FD75-2AE9-4D12-99B7-A0773C908FA9 THEATRE45 289BF0A1-0A7E-42CB-B60C-6E866CD6600F ICU AF2C5A88-9E81-4728-9B92-B44ECACF8C10 W4-AUX BFEE548B-9BE6-4641-A59C-9CA0856478D8 W2-AUX 7B4CFA5B-DB35-48D7-81E7-511AFD67D679 W6 C2B2D86F-5A19-4245-BA19-C7A15B4574C8 W6-AUX E41B4F37-175F-4F31-A880-8345B2186625 W9 9B3ED258-412C-41CD-97A2-E1EA73BA5177 W7 39198BEB-2398-4300-AE0E-4F17A0EA463B ENDOSCOPYW 8808870B-9D97-41B1-B231-DD8D03A08CED SCBU-W 5BE6B6B5-5269-482F-9651-3E106861265F ECCW-CON 491341B4-3027-44C7-8B76-50BD4BAD3F64 PUKEKO DF0D3F5D-560E-40BC-978C-021A3340DFAA WAINAMU 93FF0721-AA1A-4BED-9CFB-1187E3A214D9 KAHIKATEA 66111854-5670-4E35-B0EA-2F6A102210EA KAURI A43C5B75-B1CA-42F4-A323-C443A3A41F16 TOTARA 43F2DF70-2D69-4374-86E5-2EBAA106E95D 4KPYX_307MEDRM 2BD01247-D42F-45DC-B510-484C613334E6 W4 117D6293-5B92-4D2D-BCD4-63780DAB2FF3 W8-AUX 6587FB09-DAD3-42C5-8A11-3D656EE1FCF9 MATERNITY 75BD1C1C-D5EE-4779-A068-9D4F9D397ED6 L8NORTH FF3AAF7A-8D07-427E-8D5F-C89DE46E0A04 D110 B3517212-1A88-4A92-9138-BD94FFE96753 BERKSHIRE_pyx 542E9269-740C-4FDA-90F7-81915C4B0E8A W9-AUX A72A31DD-ED02-4586-A8E0-E600EDA99ECB NSHCDSAFE E4EDCC19-B9C7-4C7B-9D2B-CCE5768F6F27 TIAKI BE92F6A4-0281-4B91-9371-93A571E54211 THEATRE12 95EEB7D2-6C18-43BB-AA6D-235EA94A9267 BIRTHING 895CB7C6-BF21-4724-85EE-5EA53B447879 KMU12 FA9C2B26-B3BF-414E-8CD1-7472D17A4ACD W5 737BF583-9D4F-4057-A346-0D774DCC364B DIALYSIS-W 7AE4172D-2296-4107-AC24-CC03EFF22DBB THEATRE34W 24C3D56C-29B7-40EB-A973-2F9132E48EA3 MURIWAI BD17385B-189D-45D0-AACF-7900782A8484 CATHLAB BDCE97D9-0095-4FD3-AB07-096FE8887676 RECOVERY2 7A57ACBE-EA4E-4FD6-A04F-3A45B0DD18CE HDU 8799D3B4-C462-4C48-B1C9-ACEE4B63ED0D RECOVERY1 861286F6-78EE-400E-9B4B-234A7DB8688A THEATRE9 65B7B80A-4D5D-4388-AE95-33BB776C9398 ECCN-MAIN1 FF37906E-973C-4695-842E-276D20DC7EA7 AHC-NSH 0FFE4E58-CDC1-45C3-9C72-D3C7AB3F703E CCU BE67EADB-986C-4988-ACC3-E1AAFD82EA91 W14-AUX 2119302F-1B57-49EB-A13D-D043535A2F23 KERERU AC5BE7E4-EABF-4020-8CFA-3497C5AC264C RECOVERYW 966F19C2-273E-4A4D-B51F-0084E6B1EF18 DIALYSIS-N B6DAC025-3AF8-4D5A-A07A-DB5F6D15A3FB TAHAROTO 35B2BE32-6FBC-4807-B587-3CB7E4A6AD2A W10-AUX A82…
UPC codes
10885403512629, 10885403512674, 10885403477836, 10885403512667, 10885403512605, 10885403518348, 10885403520341, 10885403512520, 10885403512568

Products covered by this recall

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.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10885403512629
  • 10885403512674
  • 10885403477836
  • 10885403512667
  • 10885403512605
  • 10885403518348
  • 10885403520341
  • 10885403512520
  • 10885403512568

Model or item number

On the rating label, the box or the instruction sheet.

  • Catalog No. BD Pyxis

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

CareFusion 303, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: CareFusion 303, Inc. — 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CareFusion 303, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10885403512629, 10885403512674, 10885403477836; model number Catalog No. BD Pyxis. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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