Z-2301-2026Class II

BD Pyxis Mini Main REF: 349 Medication cabinet

Name: Z-2301-2026 BD Pyxis Mini Main REF: 349 Medication cabinet
Creator: CareFusion 303, Inc.
Published: 2026-04-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2026-04-30 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis Mini Main REF: 349 Medication cabinet on 2026-04-30. FDA classified it as Class II and gives the reason as "Fingerprint scanner may overheat to a temperature to cause 1st degree burn". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2301-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-30
Posted: 2026-06-03
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis Mini Main REF: 349 Medication cabinet
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause tag: design
FDA root cause: Component design/selection
Action: On April 30, 2026, CareFusion (subsidiary of Becton, Dickinson and Company) issued a Urgent Medical Device Recall Notification, via mail or Email. CareFusion ask consignees to take the following actions: 1. Dispensing cabinets can continue to be used as intended. 2. If you suspect that the Bio-ID Scanner is hot, please discontinue the use of Scanner and file a complaint. 3. Review and update facility policies and procedures related to situations where the Bio-ID Scanner is unavailable to mitigate delays in care. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form.
Quantity in commerce: 709 units
Distribution: US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TW
Product codes and lots: All Serial Numbers/UDI:10885403512582

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2301-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2297-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2298-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2299-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2300-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2301-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2302-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2303-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03
Z-2304-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

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)