FDA Medical devices recall ·
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P recall
- Recall number
- Z-2203-2026
- Date
- (initiated April 8, 2026)
- Company / brand
- Becton Dickinson & Co.
17200 Laguna Canyon Rd, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 183
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371
Distribution
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2203-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.