Medline Convenience Kits Recall Due to Sterility Issues

Source: FDA · United States

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Medline Industries is recalling 753 units of tracheostomy kits and trach totes nationwide due to potential sterility assurance level issues from equipment calibration problems.

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

This notice was issued by FDA on May 26, 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.

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What Happened

Medline Industries, LP has initiated a recall of certain convenience kits after identifying calibration issues with sterilization equipment. The issues have the potential to impact the sterility assurance level of the products, though all items were exposed to validated sterilization cycles.

Which Products Are Affected

The recall covers 753 units distributed nationwide in the United States and worldwide. Affected products include:

  • KIT STC TRACHEOSTOMY (Model Number: DYKMBNDL55), multiple lots including 21ABK325, 21ABX057, 21CBH955, 21DBB713, 21FBA766
  • KIT STC TRACHEOSTOMY (Model Number: DYKMBNDL55A), multiple lots including 21FBE305, 21FBS122, 21GBR275, 21GBR277, 21IBU128, 21JBJ227, 21WBA902, 22ABD970, 22ABM691, 22BBL555, 22BBM867, 22DBM224, 22DBR042, 22FBF305, 22FBX191, 22HBQ099, 22KBH787, 22LBK911, 23CBN841
  • TRACH TOTE (Model Number: DYNJ85691), Lot Number: 24ABR853

UDI-DI and case/each identifiers are provided in the recall notice. Recall number: Z-2115-2026. Classification: Class II. Initiation date: January 7, 2026.

What You Should Do

Consumers and healthcare facilities should review the affected lot numbers and contact Medline Industries, LP for return or further instructions.

Why This Matters

The potential compromise to sterility assurance could affect the safety of medical devices used in tracheostomy procedures.

Source

FDA Enforcement Report, Recall Z-2115-2026

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 753 units of tracheostomy kits and trach totes nationwide due to potential sterility assurance level issues from equipment calibration problems.
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.