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Lower risk Medical device recall · FDA · Published January 8, 2025

BD Pyxis MedStation Devices: Labeling Delays Risk Medication Access

CareFusion recalls BD Pyxis MedStation and Anesthesia Station models with insufficient labeling for medication access delays. Users should check serial numbers and software versions to determine if affected.

🇺🇸 FDA recall #Z-1120-2025Medical deviceBD Pyxis ›
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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 is recalling several BD Pyxis medical devices due to inadequate labeling that could delay access to medication. This risk is important for healthcare providers who rely on these devices for patient care. Read more at govinfonow.com/recall/53147-bd-pyxis-medstation-devices-labeling-delays-risk-medication-access.

Source Summary by GovInfoNow · govinfonow.com/recall/53147-bd-pyxis-medstation-devices-labeling-delays-risk-medication-access · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1120-2025

Cite this page

“BD Pyxis MedStation Devices: Labeling Delays Risk Medication Access.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53147-bd-pyxis-medstation-devices-labeling-delays-risk-medication-access. Based on FDA recall #Z-1120-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1120-2025%22&limit=1).

The FDA announced on Jan. 8, 2025, that CareFusion 303, Inc. is recalling BD Pyxis medication dispensing systems due to insufficient labeling regarding delays in accessing medication. The agency issued recall number Z-1120-2025 for the voluntary Class II action.

How to tell if you have it

  • BD Pyxis MedStation ES, Catalog No. 323
  • BD Pyxis Anesthesia Station (PAS), Catalog No. 327
  • BD Pyxis MedStation ES Tower, Catalog No. 352
  • BD Pyxis MedStation 4000 Console, Catalog No. 309
  • BD Pyxis MedStation 4000, Catalog No. 303
  • BD Pyxis Anesthesia System 4000, Catalog No. 338

The hazard

According to the FDA, the labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation measure.

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 Anesthesia Station 40 Recall (2026-04-30), CareFusion TLS Labeling Recall (2026-02-11), and BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03). Other recent recalls of similar products include Medline Perfusion Syringe Recall (2025-10-27), B Braun Medical Blood Set Recall (2025-10-29), and Medline Medical Kits Recall (2026-03-24).

How to tell if you have this one

Check the product's catalog number and serial number. Affected models include BD Pyxis MedStation ES (Catalog No. 323), Anesthesia Station (PAS) (Catalog No. 327), and others with specific serial numbers and software versions v1.10 or older.

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

What to do — step by step

  1. Check Product Details

    Review the catalog number, serial number, and software version to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

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

1. Firm started the recall: Jan 8, 202512. FDA classified it Class II: Feb 7, 202523. Published in FDA’s Enforcement Report: Feb 19, 202532025
  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

Do I need to stop using these devices immediately?

No, the recall does not require immediate discontinuation. The hazard is about labeling delays, not immediate safety risks.

How can I find out if my device is included in this recall?

Check the product's catalog number and serial number against the list provided in the recall notice.

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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-1120-2025 (January 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1120-2025 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