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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/Home Healthcare

MEDLINE INDUSTRIES, LP - Northfield: Medline Leg Bags Recalled Due to Undeclared Latex

Agency Publication Date: September 30, 2024
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Summary

Medline Industries is recalling 48,492 Leg Bags because they contain undeclared latex. These medical devices are used to collect urine from patients with catheters. The recall affects three specific models: DYND12574, DYND12578, and URO12573. Because the packaging does not indicate that the products contain latex, patients and healthcare providers who are allergic to latex may use them unknowingly. These products were distributed in the United States and Panama.

Risk

Latex is not listed on the product labeling, which can lead to severe allergic reactions (anaphylaxis) or skin irritation for individuals with latex sensitivities. While no specific injuries were mentioned in the recall notice, the presence of an undeclared allergen in a medical setting poses a medium risk to sensitive users.

What You Should Do

  1. Check your medical supplies for Medline Leg Bags with model numbers DYND12574, DYND12578, or URO12573.
  2. For model DYND12574, verify if your product belongs to lot numbers 48623040001, 48623050001, 48623060001, or 48623080001 with UDI/DI 40080196990338 or 10080196990337.
  3. For model DYND12578, verify if your product belongs to lot numbers 48623040001, 48623050001, 48623060001, 48623070001, or 48623080001 with UDI/DI 40080196990321 or 10080196990320.
  4. For model URO12573, verify if your product belongs to lot numbers 48623050001 or 48623060001 with UDI/DI 20888277719290 or 10888277719293.
  5. If you or the patient have a known latex allergy, stop using these bags immediately and switch to a latex-free alternative.
  6. Contact your healthcare provider or Medline Industries directly at their Northfield, Illinois headquarters for further instructions regarding replacement or a refund.
  7. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Leg bag, REF DYND12574
Model / REF:
DYND12574
40080196990338 (case)
10080196990337 (insert)
Lot Numbers:
48623040001
48623050001
48623060001
48623080001
Product: Medline Leg bag, REF DYND12578
Model / REF:
DYND12578
40080196990321 (case)
10080196990320 (insert)
Lot Numbers:
48623040001
48623050001
48623060001
48623070001
48623080001
Product: Medline Leg bag, REF URO12573
Model / REF:
URO12573
20888277719290 (case)
10888277719293 (insert)
Lot Numbers:
48623050001
48623060001

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93306
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: medical supply distributors; healthcare facilities
Manufactured In: United States
Units Affected: 3 products (28942 devices; 19406 devices; 144 devices)
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.