FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: BD Pyxis Pro MedStation Main, REF: 1155-00
- Recall number
- Z-0370-2026
- Recalling firm
- CareFusion 303, Inc.
- Product
- BD Pyxis Pro MedStation Main, REF: 1155-00
- Status
- Open, Classified
- Initiated
- 2025-09-30
- Posted
- 2025-10-27
- Terminated
- not on file
- 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 contact noted on the form whether or not you have any of the impacted material.
- Quantity
- 27 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
- Lot, serial or model codes
- All Serial Numbers/Ref #/UDI: 1155-00 10885403521300
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28