FDA-Device2026-02-18Class IIPACKAGING DEFECT

Medline Intubation Tray (Adult) recalled for incorrect suction catheter size

Nationwide distributionMedical devices

What this means

Medline Industries intubation kits (SKU DYNJAA245B, lots 25IBC172 and 25HBJ413) may contain an 8 Fr suction catheter instead of the correct 14 Fr size. The smaller catheter can block the airway during intubation, potentially causing severe breathing problems or failure that requires emergency intervention.

  • Stop using intubation kits with SKU DYNJAA245B and lot numbers 25IBC172 or 25HBJ413 immediately.
  • Check your facility's inventory and isolate affected kits.
  • Contact Medline Industries for replacement or instructions.
  • Report any use of these kits to your healthcare provider or risk management team.
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide and Canada.
Affected count
130
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2026

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