Z-1313-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- December 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130
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.
Distribution Pattern
Distribution US nationwide and Canada.
Code Information
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318