Medline Industries, LP recalls Medline medical convenience kit labeled as: TRACH TUBE KIT

Component labeling discrepancy

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.

• FDA enforcement recordOfficial FDA database entry for Z-2999-2026
• FDA device classification · OFROfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.6810The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medline Industries, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.