Medical device recalls Moderate risk

Medline Industries, LP recalls Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

Recall date
December 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1312-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
Distribution US nationwide and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

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