Medline Convenience Kits Recall Due to Sterility Issues
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,430 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.