Medline Recalls Triple Lumen Insertion Kits Over Sterilization Equipment Calibration Issues

Source: FDA · United States

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Medline Industries, LP is recalling 15 Triple Lumen Insertion Kits (Model DYNDM1031A) due to equipment calibration issues that may compromise the sterility of the medical devices.

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

This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "high" 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.

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What Happened

Medline Industries, LP has voluntarily initiated a recall of specific Triple Lumen Insertion Kits. The recall was issued after the company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the kits.

Which Products Are Affected

The recall affects 15 units of the following product:

  • Product Name: Medline Convenience Kits: KIT TRIPLE LUMEN INSERTION
  • Model Number: DYNDM1031A
  • Lot Number: 23EBM150
  • UDI-DI: 10884389555897 (individual unit); 40884389555898 (case)
  • Recall Number: Z-1407-2026

The affected products were distributed worldwide, including nationwide across the United States.

What You Should Do

Healthcare providers and distributors should immediately check their inventory for the affected lot number (23EBM150). Medline Industries, LP notified customers of the issue via a formal letter. If you possess any of the recalled units, follow the instructions provided in the firm's notification regarding the return or quarantine of the devices. For further inquiries, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Maintaining the sterility of medical insertion kits is critical for patient safety. A compromised Sterility Assurance Level increases the risk of infection or sepsis during clinical procedures involving triple lumen insertion.

Source

Information provided by the FDA under recall event ID 98329.

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 Triple Lumen Insertion Kits (Model DYNDM1031A) due to equipment calibration issues that may compromise the sterility of the medical devices.
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 "high" severity. Take precautions and monitor for updates.
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.