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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

Puracol and Puracol Plus Collagen Wound Dressings Recalled for Endotoxins

Agency Publication Date: March 27, 2026
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Summary

Medline Industries, LP is recalling approximately 106,621 units of Puracol and Puracol Plus Collagen Wound Dressings due to elevated levels of endotoxins. These sterile dressings, used for wound care, were distributed nationwide in the US and internationally to Mexico and Panama. Using these affected products can lead to serious health complications, including severe inflammatory responses or systemic infections.

Risk

The elevated endotoxin levels in the dressings can trigger a strong inflammatory response, causing local tissue irritation, delayed wound healing, or systemic effects like fever and low blood pressure. In severe cases, this condition can progress to septic shock, which is a life-threatening medical emergency.

What You Should Do

  1. Identify if you have the affected products by checking for model numbers MSC8522 (Puracol 2" x 2") or MSC8622EP (Puracol Plus 2" x 2.2").
  2. Check the packaging for specific lot numbers P2090 or PL2107 to confirm if your dressing is part of the recall.
  3. Check the UDI-DI on the individual packaging or the case: 10080196285860 / 40080196285861 (MSC8522) or 10080196296804 / 40080196296805 (MSC8622EP).
  4. Stop using the recalled product immediately.
  5. Contact Medline Industries, LP or your medical supply distributor to arrange for the return, replacement, or correction of the affected dressings.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

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: Puracol and Puracol Plus Collagen Wound Dressings
Variants: 2" X 2", 2" X 2.2"
Model / REF:
MSC8522
MSC8622EP
Lot Numbers:
P2090
PL2107
UDI:
10080196285860
40080196296804
GTIN:
40080196285861
40080196296805

MSC8522 is Puracol; MSC8622EP is Puracol Plus.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98484
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 106,621 US; 2,350 OUS
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.