Medline HEART CATH PACK-LF Kits Recall

Source: FDA · United States

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Medline Industries, LP is recalling medical convenience kits containing Namic Manifolds due to particulate in the fluid path.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline has identified the presence of particulate within the fluid path of the Manifolds in certain medical convenience kits.

Which Products Are Affected

Medline medical convenience kits, containing Namic Manifold, labeled as HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B. UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977. Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. Quantity: 0 kits. Recall number Z-2146-2026. Classification: Class I. Recall initiation date: 20260324.

What You Should Do

Consumers should refer to the recalling firm or FDA guidance for further instructions.

Why This Matters

This is a Class I recall involving devices distributed nationwide.

Source

FDA recall Z-2146-2026 (https://www.fda.gov)

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling medical convenience kits containing Namic Manifolds due to particulate in the fluid path.
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 "high" severity. Take precautions and monitor for updates.
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.