Official recall notice

FDA DeviceClass IINotable

Medline Convenience kits Recall (Jul 2026)

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

Recall date
2026-07-08
FDA class
Class II

Why it was recalled

Hazard

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.

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Product description

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.

Affected products

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

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