Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
FDA Recall #Z-1313-2026 — Class II — December 24, 2025
Product Description
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
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
130
Distribution
Distribution US nationwide and Canada.
Code Information
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated