All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
FDA device recall Z-0371-2026 · posted 2025-10-27 · Open, Classified
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- BRY
- Quantity affected
- 443 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
- Date initiated
- 2025-09-30
- Date posted
- 2025-10-27
- Location
- San Diego, CA
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