Z-0368-2026Class II

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01...

Name: Z-0368-2026 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01...
Creator: CareFusion 303, Inc.
Published: 2025-09-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-09-30 / Open, Classified

FDA source

CareFusion 303, Inc. began a recall of Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01... on 2025-09-30. FDA classified it as Class II and gives the reason as "Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0368-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-30
Posted: 2025-10-27
Recalling firm: CareFusion 303, Inc
Product: Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA root cause: Under Investigation by firm
Action: On September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.
Quantity in commerce: 2,755 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Product codes and lots: All Serial Numbers/Ref #/UDI: 1119-00 10885403512704, 1139-00 10885403512704, 139038-01 N/A, 139039-01 N/A, 139040-01 N/A, 139041-01 N/A, 139043-01 N/A, 139044-01 N/A, 139045-01 N/A, 139046-01 N/A, 139049-01 N/A, 139051-01 N/A, 139052-01 N/A, 139053-01 N/A, 139054-01 N/A, 139055-01 N/A, 139056-01 N/A, 139058-01 N/A, 139059-01 N/A, 139060-01 N/A, 139061-01 N/A, 139064-01 N/A, 139065-01 N/A, 139066-01 N/A, 139067-01 N/A, 139068-01 N/A, 139069-01 N/A, 139070-01 N/A, 139071-01 N/A, 139072-01 N/A, 139164-01 N/A, 139165-01 N/A, 300 N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0368-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0367-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27
Z-0368-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27
Z-0369-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27
Z-0370-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27
Z-0371-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-27

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)