Becton, Dickinson And Company: Introducer, Catheter
Recall Summary Becton, Dickinson and Company is recalling multiple models of Swan-Ganz catheters used in medical settings because the blue proximal injectate lumen hub may leak or break due to manufacturing and material changes, which could result in infection, medication loss, or blood loss. The affected catheters were distributed worldwide, including throughout the United States and in numerous countries in Europe, Asia, the Middle East, South America, Africa, and the Caribbean. This is a Class II recall, meaning the product could cause serious health problems but is unlikely to cause death.
- Recalling firm
- Becton, Dickinson and Company
- Product
- Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
- 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/eff9e69c-088a-458c-86f3-d9721c016a4b