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

FDA device recall Z-1312-2026 · posted 2026-02-06 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

On December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OFR

Quantity affected

141,971

Distribution

Distribution US nationwide and Canada.

Date initiated

2025-12-24

Date posted

2026-02-06

Location

Northfield, IL