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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Medline Suction Catheter Kits Recalled for Incorrect Size and Airway Risk

Agency Publication Date: February 6, 2026
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Summary

Medline Industries, LP is recalling approximately 142,101 suction catheter kits and intubation trays because a smaller 8 Fr catheter may have been packed instead of the required 14 Fr size. Using the smaller catheter can lead to serious breathing complications, including partial or full airway obstruction, which may require emergency medical intervention. Affected products include the Medline 14 Fr Suction Catheter Kit and the Adult Intubation Tray distributed across the United States and Canada.

Risk

The smaller catheter can cause hypoxia or respiratory failure due to an obstructed airway. This may lead to prolonged medical procedures, airway irritation, or death if immediate intervention is not provided.

What You Should Do

  1. Identify if you have the affected kits by checking the SKU and lot numbers on the product packaging.
  2. For the Medline 14 Fr Suction Catheter Kits (SKU DYND40972), look for Kit lot 48625040001.
  3. For the Adult Intubation Trays (SKU DYNJAA245B), check for Kit lots 25IBC172 or 25HBJ413.
  4. Stop using the recalled device immediately to avoid potential airway obstruction risks.
  5. Contact Medline Industries, LP or your distributor to arrange for the return, replacement, or correction of the affected kits.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline 14 Fr Suction Catheter Kits (respiratory convenience kit)
Model / REF:
DYND40972
Lot Numbers:
48625040001
UDI:
10080196033317
40080196033318

Recall #: Z-1312-2026; Quantity: 141,971

Product: Intubation Tray (Adult) containing Suction Catheter Kits
Model / REF:
DYNJAA245B
Lot Numbers:
25IBC172
25HBJ413
UDI:
10198459480317
40198459480318

Recall #: Z-1313-2026; Quantity: 130

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98285
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (141,971; 130)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.