Medline KIT TRIPLE LUMEN INSERTION Recall Issued

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, LP is recalling 15 units of KIT TRIPLE LUMEN INSERTION convenience kits due to potential sterility assurance issues.

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

This notice was issued by FDA on May 27, 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 has initiated a recall due to calibration issues with equipment used to sterilize and package the devices. All products were exposed to validated sterilization cycles, but the calibration issues have the potential to impact the sterility assurance level (SAL).

Which Products Are Affected

  • Product: Medline Convenience Kits - KIT TRIPLE LUMEN INSERTION
  • Model Number: DYNDM1031A
  • Lot Number: 23EBM150
  • UDI-DI: 10884389555897 (each), 40884389555898 (case)
  • Quantity: 15 units
  • Distribution: US Nationwide and worldwide
  • Recall Number: Z-2123-2026

What You Should Do

Consumers should contact Medline Industries, LP regarding the recalled products. The recall was initiated voluntarily by the firm via letter.

Why This Matters

The recall affects devices distributed nationwide where compromised sterility could impact product safety.

Source

FDA recall Z-2123-2026, event ID 98642. https://www.fda.gov

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 15 units of KIT TRIPLE LUMEN INSERTION convenience kits due to potential sterility assurance issues.
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.