Home/Recalls/FDA-Z-2612-2026
FDA DevicesClass II

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART ...

Published: July 8, 2026Recall ID: Z-2612-2026Category: devicesCountry: US

Reason for Recall / 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.

Product Description & Identification

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A

Affected Products

Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id99209
Address 13 Lakes Dr
Address 2N/A
Code infoUDI-DI 10195327033620 Lots 21KBN891 21KBO410 22ABA676 22ABY937 22BBN909 22BBT447 23ABO303
Postal code60093-2753
Report date20260708
Product typeDevices
Product quantity9,272 kits
Reason for recallKits 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260528
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260626

Overview

  • Recalling FirmMedline Industries, LP
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Official Agency Alert