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Open, Classified

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

FDA Recall Z-1313-2026 · Posted 2026-02-06

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeCAI
Date Initiated2025-12-24
Product Quantity130

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.

Firm Action

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

Distribution Pattern

Distribution US nationwide and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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