HIGH

Medline Suction Catheter Kits Recalled Due to Serious Health Risk

Medline Industries, LP recalled 141,971 suction catheter kits on December 24, 2025. The kits may contain a smaller catheter that can lead to serious respiratory issues. Health providers and patients must stop using the kits immediately to prevent potential harm.

Quick Facts at a Glance

Recall Date
December 24, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Medline 14 Fr Suction Catheter Kit is used for respiratory procedures. It is designed to assist in clearing airways in patients requiring suctioning. Healthcare professionals commonly use these kits in emergency and critical care settings.

Why This Is Dangerous

A smaller catheter, the 8 Fr, may have been mistakenly packaged instead of the necessary 14 Fr catheter. The use of the smaller catheter can lead to airway obstruction, hypoxia, or respiratory failure, which requires immediate medical intervention.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the affected suction catheter kits to prevent serious health risks. The recall emphasizes the importance of using the correct size catheter during medical procedures.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the suction catheter kit.
  2. Look for UDI codes 10080196033317 for each unit and 40080196033318 for cases.
  3. Confirm that the product is the Medline 14 Fr Suction Catheter Kit.

Where to find product info

The lot number and UDI codes are typically found on the packaging of the product.

What timeline to expect

Refund processing may take 4-6 weeks after the product is returned.

If the manufacturer is unresponsive

  • Contact Medline Industries again for follow-up.
  • Document all correspondence related to the recall.
  • Consider reporting the issue to the FDA if there is no response.

How to prevent similar issues

  • Always verify the size and specifications of medical devices before use.
  • Check for recall notices on medical devices regularly.
  • Consult with healthcare providers for alternative products when necessary.

Documentation advice

Keep records of your purchase, correspondence with Medline, and any medical consultations related to the recall.

Product Details

The recalled product is the Medline 14 Fr Suction Catheter Kits, SKU DYND40972. The affected lot number is 48625040001, with UDI codes 10080196033317 (each) and 40080196033318 (case). These kits were distributed across the United States and Canada.

Key Facts

  • 141,971 units recalled
  • Hazard: respiratory failure risk
  • Stop use immediately
  • Contact Medline for refund instructions
  • Distributed nationwide and in Canada
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSuction Catheter Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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