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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Umbilical Trays Recalled for Possible Sterile Packaging Defect

Agency Publication Date: June 20, 2025
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Summary

Medline Industries is recalling approximately 174 Medline Umbilical Trays because of a possible packaging defect in the outer Tyvec pouch designed to keep the product sterile. If this pouch is compromised, the catheters and trays may no longer be sterile, which can lead to infections during medical procedures. No incidents or injuries have been reported to date. If you possess these trays, you should stop using them and contact your healthcare provider or Medline for return instructions.

Risk

The outer packaging pouch may have a defect that prevents it from maintaining a sterile barrier for the surgical instruments inside. Using non-sterile umbilical trays on patients, particularly newborns, poses a risk of introducing bacteria and causing serious infections.

What You Should Do

  1. This recall affects Medline Umbilical Trays with 3.5 and 5 French catheters, specifically model UVT1250.
  2. Identify affected products by checking for lot numbers 25BBG881, 24KBU973, 24IBK851, or 24HBQ012 printed on the packaging.
  3. You may also verify the product using UDI-DI 10653160995340 for individual units or 40653160995341 for cases.
  4. Stop using the recalled umbilical trays immediately and secure them to prevent further use in medical procedures.
  5. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of the affected trays.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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 Umbilical Tray with 3.5 & 5FR Catheter
Variants: 3.5 & 5FR Catheter
Model / REF:
UVT1250
Lot Numbers:
25BBG881
24KBU973
24IBK851
24HBQ012
UDI:
10653160995340
40653160995341

Possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96959
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medical distributors
Manufactured In: United States
Units Affected: 174 units
Distributed To: Virginia

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.