FDA Recall of Medline Namic Guidewires

Source: FDA · United States

Medline Industries, LP is recalling 74,085 units of various Namic Guidewires due to rescinded 510(k) regulatory clearances, affecting products distributed nationwide in the United States.

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

This notice was issued by FDA on May 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 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 Industries, LP is recalling certain guidewires because the 510(k) regulatory clearances for these products have been rescinded.

Which Products Are Affected

The recall involves multiple models of Medline Namic Guidewires, including: 1) GUIDEWIRE 3MMJ 0.035X260CM LT (Model: DYNJGWIRE20L), 2) GWIRE HYDRO 0.035 180CM ANG S (Model: DYNJHWIRE105), 3) GWIRE HYDRO 0.035 260CM ANG S (Model: DYNJHWIRE107), and up to 30 models as listed. A total of 74,085 units are affected, with specific lot numbers such as 34125030001, 24LBR925, and others. The products have UDI-DI codes like 10195327188955 and were distributed nationwide in the United States. The official recall number is Z-1829-2026.

What You Should Do

Consumers and healthcare providers should follow the firm's initial notification, which was sent via letter, and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for instructions on returns or refunds.

Why This Matters

This recall addresses potential regulatory issues with medical devices, ensuring that only properly cleared products are used in healthcare settings to maintain safety standards.

Source

This information is from the FDA recall database, attributed to recall number Z-1829-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 74,085 units of various Namic Guidewires due to rescinded 510(k) regulatory clearances, affecting products distributed nationwide in the United States.
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.