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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Sterile Convenience Kits Recalled for Lack of Sterilization

Agency Publication Date: September 26, 2025
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Summary

Medline Industries, LP is recalling approximately 110 Sterile Medline Convenience Kits because they were labeled as sterile but did not undergo the required sterilization process. The recall includes the Major Pack L-F, LB Basic Custom Pack, and Extremity Pack kits. Consumers and facilities should stop using these products immediately to prevent potential health complications.

Risk

Using medical kits that have not been properly sterilized poses a critical risk of serious infection. These non-sterile devices can introduce bacteria or other pathogens directly into patients during medical procedures, potentially leading to life-threatening complications.

What You Should Do

  1. This recall affects Medline Sterile Convenience Kits including the Major Pack L-F, LB Basic Custom Pack, and Extremity Pack models.
  2. Check the model number and lot number printed on the product label. Affected kits include model numbers DYNJ0382730O (Lot 25GBC583), DYNJ61038B (Lot 25GBF720), and DYNJ45701B (Lot 25GBF686).
  3. Stop using the recalled medical kits immediately.
  4. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of the products.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for any 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: Sterile Medline Convenience Kits: MAJOR PACK L-F
Model / REF:
DYNJ0382730O
Lot Numbers:
25GBC583
UDI:
10198459117992
GTIN:
40198459117993

Each and case identifiers provided.

Product: Sterile Medline Convenience Kits: LB BASIC CUSTOM PACK
Model / REF:
DYNJ61038B
Lot Numbers:
25GBF720
UDI:
10195327596316
GTIN:
40195327596317

Each and case identifiers provided.

Product: Sterile Medline Convenience Kits: EXTREMITY PACK
Model / REF:
DYNJ45701B
Lot Numbers:
25GBF686
UDI:
10193489856279
GTIN:
40193489856270

Each and case identifiers provided.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97495
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Medical distributors; Direct to healthcare facilities
Manufactured In: United States
Units Affected: 2 products (22 units; 88 units)
Distributed To: Florida, Maryland, New Jersey, Tennessee

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.