FDA-Device2026-07-08Class IIPROCESSING DEFECT

Medline Convenience kits with recalled Swan-Ganz catheters for hub leakage risk

OTHERNationwide distributionMedical devices

What this means

Medline Convenience kits contain Swan-Ganz catheters that were recalled by manufacturer Becton Dickinson due to failures in the blue proximal injectate lumen hub. These failures can cause leaks, lumen damage, and breakage, potentially leading to infection, medication loss, or blood loss.

  • Check if your facility has these kits (Model DYNJ8407, UDI-DI 10198459704543, Lot 26DBB599)
  • Stop using affected kits immediately
  • Consult with your healthcare provider or facility infection control/clinical engineering about device management and patient safety steps
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Affected count
9,272 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2608-2026

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