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Open, Classified

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

FDA Recall Z-2999-2026 · Posted 2026-08-21

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOFR
Date Initiated2026-07-10
Product Quantity45 kits

Reason for Recall

Component labeling discrepancy

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the state of California.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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