Medline Industries, LP recalls Medline medical convenience kit labeled as: TRACH TUBE KIT
Reason for recall
Component labeling discrepancy
Affected product
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Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKUDYKM2330Affected lot26FLA408
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the state of California.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- 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.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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