Medline Industries Recalls Convenience Kits Over Potential Sterility Assurance Issues

Source: FDA · Worldwide

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Medline Industries, LP has issued a voluntary recall for 32 units of convenience kits due to equipment calibration issues that may compromise product sterility.

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

This notice was issued by FDA on March 3, 2026 and geographically references Worldwide. 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 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 initiated a voluntary Class II recall of specific convenience kits after identifying calibration issues with equipment used for sterilization and packaging. While the products were processed through validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall involves 32 units of the following medical device:

  • Product Name: Medline Convenience Kits: WMC I D PACK-LF
  • Model Number: DYNJ50806L
  • Lot Number: 23FBK937
  • UDI-DI: 10195327344672 (each), 40195327344673 (case)
  • Recall Number: Z-1403-2026

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

What You Should Do

Consumers and healthcare providers should immediately inspect their inventory for the affected lot number (23FBK937). Medline Industries notified customers of the issue via a formal letter initiated on January 7, 2026. If you are in possession of the recalled kits, follow the instructions provided in the firm's notification regarding the return or quarantine of the product. For further inquiries, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

Compromised sterility in medical kits poses a risk of infection or other adverse health complications for patients. This recall ensures that potentially non-sterile equipment is removed from clinical use to maintain patient safety.

Source

Recall information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP has issued a voluntary recall for 32 units of convenience kits due to equipment calibration issues that may compromise product sterility.
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 Worldwide. 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.