FDA Recall of Medline Namic Guidewires
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Medline Industries, LP is recalling 74,085 units of various Namic Guidewires due to rescinded 510(k) regulatory clearances, affecting products distributed nationwide in the United States.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 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Industries, LP is recalling certain guidewires because the 510(k) regulatory clearances for these products have been rescinded.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 ↗
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 (1,280 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.