Medline recalls 14 Fr Suction Catheter Kits (SKU DYND409:48625040001) due to possible inclusion of smaller 8 Fr catheters causing airway obstruction and respiratory failure.
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.
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Contact the company
📍Recalling firmMedline Industries, LP3 Lakes Dr · Northfield, IL 60093-2753
“Medline 14 Fr Suction Catheter Kits Recall: Risk of Airway Obstruction.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50344-medline-14-fr-suction-catheter-kits-recall-risk-of-airway. Based on FDA recall #Z-1312-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2026%22&limit=1).
The FDA announced on Dec. 24, 2025, that Medline Industries, LP is recalling Medline 14 Fr Suction Catheter Kits due to a hazard involving the wrong catheter size being packed in the kit. The agency stated that use of the incorrect smaller catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction.
The recall involves kits where a smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed 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.
Context
GovInfoNow's records show Medline Industries, LP has had 68 other recalls since July 31, 2025. Other recent recalls of similar products include Medline Basic Homecare Beds and Medlite Homecare Beds (Aug. 14, 2026), Medline Convenience Kits (Aug. 11, 2026), and Medline Sinus Packs (Aug. 10, 2026). Other recent recalls of similar products include SunMed Tracheal Tube Size 2.5 (July 31, 2026), Philips Bridge Prep Kit (April 2, 2026), and American Contract Systems Convenience Kit (June 29, 2026).
How to tell if you have this one
Check for the SKU DYND40972 and lot number 48625040001 on the kit packaging. The kit is sold as a respiratory convenience kit.
Brand
Medline
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1312-2026 (December 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1312-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.