Medical Device Recall: Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Medline Industries, LP · December 24, 2025
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
Distribution US nationwide and Canada.
States Affected
NATIONWIDE
Quantity Affected
141,971
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1312-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.