Z-1312-2026 Class II Ongoing
FDA device recall Z-1312-2026 was initiated by Medline Industries, LP on December 24, 2025 and is designated Class II. 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 a… The recall status is ongoing. Affected quantity: 141,971.
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
- 141,971
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.
Distribution Pattern
Distribution US nationwide and Canada.
Code Information
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿