FDA-Device2026-02-18Class IIPACKAGING DEFECT

Medline 14 Fr Suction Catheter Kits recalled for wrong catheter size

Nationwide distribution

Stop using Medline suction catheter kit DYND40972

Some Medline 14 Fr Suction Catheter Kits (SKU DYND40972) may contain a smaller 8 Fr catheter instead of the correct 14 Fr size. Using the wrong size catheter can partially or completely block the airway, leading to low oxygen levels and breathing failure that may require emergency treatment.

  • Check your kit SKU DYND40972 for lot number 48625040001
  • Do not use the kit if you have the affected lot number
  • Contact your supplier or Medline for a replacement
  • If a patient shows signs of airway obstruction or low oxygen after using this kit, seek emergency medical care immediately
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.

Sold states
Distribution US nationwide and Canada.
Affected count
141,971
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2026

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief