FDA Recall of Medline Convenience Kits Due to Unapproved Design Changes

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 270,311 units of specific convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes outside of 510(k) clearance.

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, cpsc, 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 conducting a voluntary recall of certain convenience kits due to unapproved design changes to the products that were made outside of the 510(k) clearance.

Which Products Are Affected

The affected products include Medline Convenience Kits with the following SKUs: BIOPSY PACK (DYNJ38587A and DYNJ38587B), BIOPSY/DRAINAGE TRAY-LF (DYNJ30078D), and W LINQ PACK (DYNJ59108B). The total quantity affected is 270,311 units. Specific code information includes: For DYNJ38587A, UDI-DI 10193489754070 (EA) and 40193489754071 (CS) with lots such as 20BBF696, 20EBH917; for DYNJ38587B, UDI-DI 10195327397326 (EA) and 40195327397327 (CS) with lots like 23DBP789; for DYNJ30078D, UDI-DI 10889942138647 (EA) and 40889942138648 (CS) with lots including 23CBK546; and for DYNJ59108B, UDI-DI 10198459138461 (EA) and 40198459138462 (CS) with lot 24JBP861. The distribution is nationwide in the US and also includes Canada, Panama, and Barbados.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Medline Industries, LP, for further instructions regarding the recall.

Why This Matters

This recall affects over 270,000 units of medical devices, highlighting potential risks from unapproved changes that could impact product safety and compliance in healthcare settings.

Source

FDA recall notice Z-1879-2026, 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 is recalling 270,311 units of specific convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes outside of 510(k) clearance.
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.