Open, Classified

BD Pyxis(TM) Anesthesia Station 4000, REF: 338

FDA Recall Z-1932-2024 · Posted 2024-05-30

Recalling FirmCareFusion 303, Inc.

Recall StatusOpen, Classified

Product CodeBRY

Date Initiated2024-04-15

Product Quantity11,875 units

Reason for Recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Firm Action

On May 2, 2024, CareFusion, a subsidiary of Becton, Dickinson and company issued a "Urgent Medical Device Correction", to affected consignees. 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

Component design/selection

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.