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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 Sterile Radiology Procedure Kits Recalled for Packaging Breach

Agency Publication Date: March 27, 2026
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Summary

Medline Industries, LP is recalling 420 Sterile Radiology Procedure Kits (Model Number DYNDH1491B) because the sterile pouch packaging may be breached. This potential defect could compromise the sterility of the medical instruments inside the kit. Consumers and healthcare facilities should stop using the affected kits immediately and contact the manufacturer to arrange for their return, replacement, or correction.

Risk

A breach in the sterile packaging can expose the medical instruments to environmental contaminants and microorganisms. Using non-sterile instruments during radiology procedures significantly increases the risk of serious infection or other medical complications for the patient.

What You Should Do

  1. Identify your product by checking the packaging for Model Number DYNDH1491B and Lot Number 25GBB924.
  2. Check the Unique Device Identifier (UDI) codes on the labels: (CS) 40198459071455 or (EA) 10198459071454.
  3. Stop using the recalled product immediately to prevent the risk of infection.
  4. Contact Medline Industries, LP or your distributor to arrange for the return, replacement, or correction of the affected radiology kits.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

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

Affected Products

Product: Sterile Radiology Procedure Kits
Model / REF:
DYNDH1491B
Lot Numbers:
25GBB924
UDI:
40198459071455
10198459071454

Quantity affected: 420 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98529
Status: Active
Manufacturer: Medline Industries, LP
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 420 units
Distributed To: Minnesota

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.