Becton, Dickinson and Company has been subject to an enforcement report issued by the US Food and Drug Administration regarding Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. Product Quantity: 183.
Recall Number: Z-2203-2026. Code Information: Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(June 24, 2026), 66010501(September 23, 2026), 67122784(October 28, 2027); SGPT54/00690103219289/65956343(August 19, 2026); SGPT64P/00690103219371. Classification: Class II.
Event ID: 98603. Voluntary: Firm initiated. Product Type: Devices.
Status: Ongoing. Distribution Pattern: Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada. Recall Initiation Date: April 8, 2026.
Center Classification Date: May 15, 2026.
