Z-1375-2025Class II

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe...

Name: Z-1375-2025 BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe...
Creator: CareFusion 303, Inc.
Published: 2025-02-06
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-02-06 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF... on 2025-02-06. FDA classified it as Class II and gives the reason as "Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1375-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-06
Posted: 2025-03-17
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Root cause tag: software
FDA root cause: Software design
Action: On 2/6/2025, correction notices were mailed to customers informing them of the following: 1) Firm will be contacting customers and distributors to schedule time to upgrade software to 1.7.4.138 or a later release. 2) Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. 3) Complete and return the customer/distributor response form via email to [email protected] Report complaints to firm via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am - 5:00pm CT Email: [email protected] Recall/Remediation Related Questions: 1-866-583-8783, 8:00am ET to 7:00pm ET), Monday - Friday. Product Complaints or Technical Support: 1-800-727-6102 Phone hours: 24 hours, 7 days a week Website: bd.com/self-service
Quantity in commerce: 727
Distribution: Worldwide - US Nationwide distribution including in the states of KY, OH, NY, MO, NC, PA, FL, TN, CT, LA, MN, VA, MD, CA, TX, NE, IA, OK, MI, PR, SD, IN, ME, KS, IL, NM, WA, AR, HI, MS, GA, WY, WI, VT, AL, NV, NJ, DC, AZ, MT, AK, OR, CO, NH, MA, SC, ID, UT, ND and the countries of TW, CA, AE, MX, SG, AU, NZ, GB, CH, BH.
Product codes and lots: BD Pyxis Enterprise Server software versions: 1.7.4.128, 1.7.4.134, 1.7.4.136, 1.7.4.137, All 1.7.1, All 1.7.2, All 1.7.3. REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674, 1116-00/10885403512605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1375-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)