Medline Industries Recalls Adult Intubation Trays Over Life-Threatening Catheter Size Error

What Happened

Medline Industries, LP has initiated a voluntary recall of specific Intubation Trays (Adult) due to a packaging error. The company discovered that an 8 Fr suction catheter may have been included in the kits instead of the required 14 Fr suction catheter. The use of a smaller-than-intended catheter poses significant health risks, including hypoxia, respiratory failure, and partial or full airway obstruction. Such obstructions may require immediate emergency medical intervention to prevent death.

Which Products Are Affected

The recall involves 130 units distributed nationwide in the United States and Canada. Affected products include:

• Product Name: Intubation Tray (Adult) containing Suction Catheter Kits
• SKU: DYNJAA245B
• Lot Numbers: 25IBC172 and 25HBJ413
• UDI (each): 10198459480317
• UDI (case): 40198459480318
• Recall Number: Z-1313-2026

What You Should Do

Healthcare providers and facilities should immediately inspect their inventory for the affected SKU and lot numbers listed above. Medline Industries began notifying customers via letter on December 24, 2025. Any affected trays should be set aside and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacements, contact Medline Industries, LP directly.

Why This Matters

This recall is critical because the incorrect catheter size can lead to life-threatening complications during intubation procedures, including airway irritation, prolonged dyspnea, or fatal respiratory failure if the airway becomes obstructed.

Source

Information provided by the FDA under recall event ID 98285.