RecallRadar

FDA Device recall Z-2611-2026

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

On 2026-07-08 the FDA classified a Class II recall of Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M by Medline Industries, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2611-2026
ClassificationClass II
Statusongoing
Initiated2026-05-28
Published2026-07-08
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

Reason

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.

Identifiers

code_info
DYNJ909090B UDI-DI 10195327652432 Lots 24EBL051 24GBG271 CDS982523M UDI-DI 10195327560591 Lots 24ALA22…DYNJ909090B UDI-DI 10195327652432 Lots 24EBL051 24GBG271 CDS982523M UDI-DI 10195327560591 Lots 24ALA227 24BLA369 24CLA108 24CLA518 24DLA082 24ELB053 24ILA112

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2611-2026%22

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