Z-1223-2024Class II

BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352

Name: Z-1223-2024 BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352
Creator: CareFusion 303, Inc.
Published: 2024-02-01
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2024-02-01 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352 on 2024-02-01. FDA classified it as Class II and gives the reason as "Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential...". 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-1223-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-01
Posted: 2024-08-20
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
Root cause tag: software
FDA root cause: Software design
Action: On 2/1/24, correction notices were mailed or emailed to customers and distributors who were told the following: Devices with a random application hang, freeze and/or crashing can be resolved with a reboot of the device. In downtime scenarios, medications can be obtained from other devices or from pharmacy. There are also keys that can be used to manually access contents within the device. 1) Ensure you continue to manually reboot your devices as a part of your maintenance schedule. 2. Disseminate this notification within your facility network to ensure they are aware of the issue. 3. If you experience this issue, please contact Technical Support. 4. Complete the Customer Response Form and return to [email protected] If you require further assistance, please contact the firm: Customer Support: 1-866-583-8783, 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday. Technical Support: bd.com/self-service, 1-800-727-6102, 24 hours, 7 days a week
Quantity in commerce: 20,443
Distribution: Worldwide distribution - US Nationwide distribution including in the states of VA, SC, IL, AL, KS, LA, GA, FL, CA, PR, PA, WV, WA, HI, NC, MD, AR, NY, ND, TX, NM, GU, MS, AZ, DC, AK, NE, DE, CO, SD, MO, NJ, OK, NV, OH, KY, WY, MT, UT, ID, MA, MI, MP, NH, IA, TN, CT, RI, IN, WI, OR, MN, VT, ME and the countries of BH, DE, GB, IT, JP, ES, GU, KR, BE, AR, BR, BS, CL, CO, MX, AE, AU, CA, EG, FR, HK, MY, NZ, QA, SA, TH, NL, MC, CH, FI, JO, KW, LB, OM.
Product codes and lots: REF/UDI-DI: 323/10885403512667, 327/10885403477836, 352/10885403512674. All Using Software Version ES System Release 1.4.x, 1.5.x and 1.6.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1223-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

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)