Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
FDA Recall #Z-1312-2026 — Class II — December 24, 2025
Product Description
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
141,971
Distribution
Distribution US nationwide and Canada.
Code Information
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated