Recall Z-0368-2026 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
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
| Date | Oct 27, 2025 (initiated Sep 30, 2025) |
| Status | Open, Classified |
| Reason | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 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 |
| Quantity | 2,755 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.