← FDA ENFORCEMENT
Z-2606-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Firm state
IL
Product quantity
9,272 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

Product description

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B

Code / lot info

UDI-DI 10195327345044 Lots 23DBI807 23FBG708 23GBK642 23KBO477 24BBG198 24FBN889 24GBJ879 24HBR045 24LBT492 25ABL957 25BBN572 25GBT734 25HBQ817 25LBM617 26BBK766 26DBE720

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.