Becton, Dickinson And Company: Catheter, Flow Directed
Recall Summary Becton, Dickinson and Company is recalling three models of Swan-Ganz Jr Catheters (SGPT54, SGPT64P, SGPT755P) due to manufacturing changes that may cause the blue proximal injectate lumen hub to leak or break, potentially resulting in infection, medication loss, or blood loss. The affected catheters were distributed worldwide, including throughout the United States and multiple international locations. This is a Class II recall, which means the product could cause serious adverse health effects or temporary or medically reversible adverse health consequences.
- Recalling firm
- Becton, Dickinson and Company
- Product
- Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/23b2c461-d8a5-4c42-859b-b9ef08ff03b4