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
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
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2026 | Recall initiated by company | |
| 21 Aug 2026 | Classified by FDA | +42 days |
| 2 Sep 2026 | Published 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.
Questions about this recall
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |