Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard
Medline recalls medical convenience kit TRACH TUBE KIT (SKU DYKM2330) due to labeling discrepancy. Affected units have specific UDI/DI and lot numbers. No remedy stated in official notice.
Lower-risk recall
Component labeling discrepancy
What happened, in plain English
Medline is recalling a medical convenience kit labeled as TRACH TUBE K: the kit has a labeling discrepancy that could cause confusion. This recall affects specific units with the UDI/DI 10198459582158 (each) and 40198459582159 (case), lot number 26FLA408. The issue does not pose an immediate safety risk but requires correction to prevent misidentification. Read more at govinfonow.com/recall/697907-medline-trach-tube-kit-recall-labeling-discrepancy-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/697907-medline-trach-tube-kit-recall-labeling-discrepancy-hazard · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2999-2026
Cite this page
“Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697907-medline-trach-tube-kit-recall-labeling-discrepancy-hazard. Based on FDA recall #Z-2999-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2999-2026%22&limit=1).
Why it’s dangerous
The labeling discrepancy means the kit's name and identifiers don't match the actual product. This could lead to incorrect identification or use of the kit, potentially causing errors in medical procedures. However, the issue does not involve physical harm or immediate safety risks.
Who’s affected
Medical professionals and facilities using Medline's TRACH TUBE KIT (SKU DYKM2330) with the specified UDI/DI and lot numbers are affected. Those handling medical equipment without proper labeling may be at higher risk of confusion.
How to tell if you have this one
Check for the label 'TRACH TUBE KIT' and the specific UDI/DI numbers: 10198459582158 (each) and 40198459582159 (case), with lot number 26FLA408. The kit is sold under Medline Industries, LP.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Label Details
Verify the UDI/DI numbers and lot number on the kit to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of California.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2999-2026 (July 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2999-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.