CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline medical convenience kit labeled as: Trach Tube Kit recalled

Medline Industries is recalling Medline medical convenience kit labeled as: Trach Tube Kit, Medline Kit, distributed nationwide in the US. The recall was initiated on 10 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408
Quantity recalled45 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2999-2026
FDA event ID
99506
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
10 Jul 2026
FDA classified
21 Aug 2026
Reported
2 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

10 Jul 2026Recall initiated by company
21 Aug 2026Classified by FDA+42 days
2 Sep 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Component labeling discrepancy

Product as listed by the FDA

Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330

Where it was distributed

US Nationwide distribution in the state of California.

Nationwide California

Questions about this recall

Is Medline medical convenience kit labeled as: Trach Tube Kit, Medline Kit recalled?

Yes. Medline Industries recalled Medline medical convenience kit labeled as: Trach Tube Kit, Medline Kit on 10 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2999-2026.

Why was it recalled?

Component labeling discrepancy

Which lots are affected?

UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408

Where was it sold?

US Nationwide distribution in the state of California.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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