Recall Z-2202-2026— Becton, Dickinson and Company
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, initiated 2026-04-08. It names 2 FDA 510(k) clearances: K233824, K231248. 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..
- Recalling firm
- Becton, Dickinson and Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-08
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K233824 — Swan-Ganz catheter
- K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.