Recall Z-2204-2026— Becton, Dickinson and Company

Name: FDA recall Z-2204-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Class II · Ongoing

Class II FDA medical device recall by Becton, Dickinson and Company, initiated 2026-04-08. It names one FDA 510(k) clearance: K233983. Product: Swan-Ganz Pacing Catheter, Models: D200F7;. 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

1 on FDA's record

K233983 — Swan-Ganz Pacing Probe and Catheters +4 moreEdwards Lifesciences·cleared 2024-06-27

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 Pacing Catheter, Models: D200F7;

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.