BD Pyxis Product Name / UDI-DI code /
Medical device recall Z-2477-2025. Published in FDA’s Enforcement Report on Sep 3, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 3, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 54 states named
- 8353 devices (6738 U.S. and 1615 O.U.S.) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Antivirus software was not consistently installed on impacted devices during the implementation process.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
8353 devices (6738 U.S. and 1615 O.U.S.), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,976 characters
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…
FDA’s list runs to 433,987 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
54 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- 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 FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 8, 2025.
- FDA classified it on Aug 28, 2025.
- FDA’s Enforcement Report published it on Sep 3, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 433,987 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.