Medline Convenience Kits Recall Involving Swan-Ganz Catheters

Source: FDA · United States

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 is recalling 9,272 convenience kits containing Swan-Ganz catheters due to potential leaks and breakage in the proximal injectate lumen hub.

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, Devices.

What Happened

Medline Industries, LP initiated a voluntary recall of convenience kits containing Swan-Ganz catheters. The kits include catheters recalled by Becton Dickinson (BD) due to complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub, which may lead to leakage, lumen damage, breakage, infection, medication loss, and/or blood loss.

Which Products Are Affected

The affected product is Medline Convenience kits containing recalled Swan-Ganz Catheters, specifically RIGHT HEART CATH PACK CTX DYNJ68530A. A total of 9,272 kits are involved under UDI-DI 10195327033620 with lots 21KBN891, 21KBO410, 22ABA676, 22ABY937, 22BBN909, 22BBT447, 23ABO303. Distribution was nationwide in the United States, specifically in AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, and WI. The recall number is Z-2612-2026 and it is classified as Class II.

What You Should Do

Consumers should refer to the recalling firm or FDA for guidance on the ongoing recall.

Why This Matters

The recall addresses potential risks of infection, medication loss, and blood loss from the affected devices distributed across multiple states.

Source

FDA recall Z-2612-2026, event ID 99209 (Medline Industries, LP)

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries is recalling 9,272 convenience kits containing Swan-Ganz catheters due to potential leaks and breakage in the proximal injectate lumen hub.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.