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Lower risk Medical device recall · FDA · Published December 3, 2025

BD Pyxis ES Enterprise Server Software Update Issue Recall

Recall of BD Pyxis ES Enterprise Server devices with specific catalog numbers and software versions due to potential failure to receive timely patient and medication updates from enterprise systems.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1028-2026Medical deviceBD ›
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Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

CareFusion recalls BD Pyxis ES Enterprise Server devices that may not receive timely updates of patient or medication information from connected systems. This could lead to errors in medication administration if the system fails to communicate properly with enterprise systems. Read more at govinfonow.com/recall/50537-bd-pyxis-es-enterprise-server-software-update-issue-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/50537-bd-pyxis-es-enterprise-server-software-update-issue-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1028-2026

Cite this page

“BD Pyxis ES Enterprise Server Software Update Issue Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50537-bd-pyxis-es-enterprise-server-software-update-issue-recall. Based on FDA recall #Z-1028-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2026%22&limit=1).

The FDA announced on Dec. 3, 2025, that CareFusion 303, Inc. is recalling BD Pyxis ES Enterprise Servers due to a software issue that may prevent timely updates of patient or medication information. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: BD
  • Product: BD Pyxis ES Enterprise Server
  • Catalog Numbers: 1115-00, 137672-02, 137672-03, 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01, 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03, 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01
  • System Versions: 1.6.1 - 1.11.0
  • Server Application Versions: ES 5.4X - 5.8.X or ES 4.13 - 5.8.X
  • Units affected: 2,079 systems

The hazard

According to the FDA, a software issue may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

Context

GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. Other recent recalls of similar products include BD Pyxis MedStation ES REF 323 Medication Cabinet Recall (2026-04-30), CareFusion labeling recall (2026-02-11), and CareFusion Pyxis MedStation ES Firmware Update recall (2025-11-20). Other recent recalls of similar products include Philips Patient Information Center iX Software Freezes (2026-07-31), IntelePACS Software Update recall (2025-10-17), and GE HealthCare ApexPro v6.0 eDelivery Software Recall (2026-04-24).

How to tell if you have this one

Check if your BD Pyxis ES Enterprise Server has catalog numbers listed in the recall (e.g., 1115-00, 137672-02) and software versions 1.6.1 to 1.11.0 with server applications ES 4.13 to 5.8.X.

  • Brand
    BD
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Catalog Number

    Identify your BD Pyxis ES Enterprise Server's catalog number from the list provided in the recall notice.

  2. Verify Software Version

    Confirm your device's software version is within the range 1.6.1 to 1.11.0 with server applications ES 4.13 to 5.8.X.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Dec 3, 202512. FDA classified it Class II: Jan 8, 202623. Published in FDA’s Enforcement Report: Jan 14, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these devices immediately?

No, the recall does not require immediate stop use. The hazard is described as a potential communication issue, not an immediate safety risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1028-2026 (December 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1028-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA