Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may result in infection, medication loss, or blood loss.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device (per agency classification) with specific failure modes that could result in serious harms including infection and blood loss. Although no reported illnesses or injuries are stated in the source text, the potential risk of harm and the specific nature of the defect (lumen hub failure leading to leakage/breakage) justify a High severity rating per the rubric.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits that contain Swan-Ganz catheters originally recalled by Becton Dickinson (BD). The kits are affected across multiple product lines and catalog numbers, including CABG A, CARDIAC MAJOR, HEART A, HEART TRAY-VASCULAR, and various OPEN HEART kit configurations.
BD has received complaints involving failures of the blue proximal injectate lumen hub on the catheters included in these kits. These failures have resulted in leaks, lumen damage, and breakage. These issues may lead to infection, medication loss, and blood loss.
Approximately 9,272 kits have been distributed nationwide to hospitals and healthcare facilities in Arizona, California, Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas, and Wisconsin. Healthcare facilities that have received affected kits should stop using them immediately and contact their Medline representative or Becton Dickinson for instructions on returns and replacements.
Patients who have received care involving these catheters should consult with their healthcare provider if they experience signs of infection, unusual bleeding, or other complications related to their procedure.
The recalled product
- Product
- Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ90
- Manufacturer
- Medline Industries, LP
- Hazard
- lumen-hub-failure
- leakage
- infection-risk
- blood-loss
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide
FDA (Devices) · 2026-07-08
- ModerateZeiss Intrabeam Spherical Applicator failed manufacturing specifications
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided 12-15mm Esophageal Stent Recall
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08