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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJuly 10, 2026
Date PostedAugust 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2999-2026
Recall Event ID 99506
Product Classification Tracheobronchial suction catheter kit - Product Code OFR
ProductMedline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Code Information UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Component labeling discrepancy
FDA Determined
Cause 2		Labeling Change Control
ActionMedline 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 Commerce45 kits
DistributionUS Nationwide distribution in the state of California.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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