FDA-Device2026-09-02Class IIMISBRANDING
Medline tracheostomy tube kit recalled for component labeling discrepancy
What this means
Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.
- Check if you have Medline trach tube kit SKU DYKM2330, lot number 26FLA408
- Contact Medline Industries or your healthcare provider for instructions on the correct contents
- Do not use the kit until you have confirmed the correct component contents with your provider
The agency's original wording
Hazard
Component labeling discrepancy
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of California.
Affected count
45 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2999-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
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