Medline Industries Recalls Medical Devices Due to Regulatory Issues

Source: FDA · United States

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Medline Industries, LP is recalling 58,836 units of certain medical kits because their regulatory clearances were rescinded, affecting nationwide distribution.

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

This notice was issued by FDA on May 8, 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 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 medical devices because the 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which Products Are Affected

The affected products are: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A. A total of 58,836 units are involved, distributed nationwide in the United States. Specific lot numbers include: for DYNJSYR10CWRB, lots such as 22IBH073, 22IBH620, 22KBU236, and others up to 25CBN329; for VASCSLPOFF1, lots 24KBI875 and 23KBD992; for VASC1018A, lots 25BBG137, 25BBI161, and 25ABG686. UDI-DIs include 10889942540570 for DYNJSYR10CWRB, 10889942405527 for VASCSLPOFF1, and 10889942337033 for VASC1018A.

What You Should Do

Consumers who have these products should contact Medline Industries, LP for instructions, as the recall was initiated via letter.

Why This Matters

This recall involves over 58,000 units of medical devices used in procedures, potentially affecting patient safety due to regulatory issues.

Source

FDA recall notice Z-1833-2026, attributed to the U.S. Food and Drug Administration (FDA).

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 58,836 units of certain medical kits because their regulatory clearances were rescinded, affecting nationwide distribution.
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.