Medline Convenience Kits Recall Due to Swan-Ganz Catheter Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP is recalling 9,272 convenience kits containing Swan-Ganz catheters distributed nationwide due to potential leaks, breakage, and infection risks.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Medline Industries, LP initiated a voluntary recall of convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson (BD). The kits are subject to complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Which Products Are Affected
The recall covers 9,272 kits distributed to AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, and WI. Affected products include Medline Convenience kits such as CABG A CDS (CDS982269K, CDS982269L, CDS982269M, CDS982269N), CARDIAC MAJOR (DYNJ901328D, DYNJ901328F), HEART A (DYNJ903465F, DYNJ903465G), and numerous others including HEART TRAY-VASCULAR, OPEN HEART, OPEN HEART ACCESSORY CDS, OPEN HEART ANESTHESIA PACK, and additional listed models with specific UDI-DIs and lot numbers detailed in FDA recall Z-2613-2026.
What You Should Do
The recall is classified as Class II and was initiated voluntarily by the firm with initial notification via email, fax, letter, press release, telephone, or visit.
Why This Matters
The affected kits are used in cardiac procedures across multiple states and pose risks of infection or fluid loss if the catheter hubs fail.
Source
FDA Enforcement Report, recall number Z-2613-2026, event ID 99209.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,305 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.