Z-2999-2026Class II

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

Name: Z-2999-2026 Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Creator: Medline Industries, LP
Published: 2026-07-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-10 / Open, Classified / root cause: labeling and UDI

FDA source

Medline Industries, LP began a recall of Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330 on 2026-07-10. FDA classified it as Class II and gives the reason as "Component labeling discrepancy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2999-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-10
Posted: 2026-08-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Product code: OFR Tracheobronchial Suction Catheter Kit
Reason for recall: Component labeling discrepancy
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Medline Industries issued an URGENT MEDICAL DEVICE CORRECTION notice to its sole consignee on 7/10/2026 via USPS and email. The notice explained the issue, potential risk, and attached the notice from Medtronic. The notice from Medtronic provided the following information: "Customer Actions: " Customers can continue to use the Covidien Shiley" disposable decannulation plugs. " Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue. " Share this notice with all relevant personnel within your organization, and with any organization to which the affected product has been transferred or distributed." Medline requested a response through their portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-115-FGX2.
Quantity in commerce: 45 kits
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2999-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2999-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

Product code OFR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)