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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 FirmDecember 24, 2025
Date PostedFebruary 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1312-2026
Recall Event ID 98285
Product Classification Tracheobronchial suction catheter kit - Product Code OFR
ProductMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Code Information Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply.
Quantity in Commerce141,971
DistributionDistribution US nationwide and Canada.
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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