FDA-Device2026-04-01Class IIPROCESSING DEFECT
Medline Puracol and Puracol Plus collagen wound dressings recalled for elevated endotoxin levels
OTHERNationwide distribution
Stop using Medline Puracol wound dressings
Medline Industries has recalled specific lots of Puracol and Puracol Plus collagen wound dressings due to elevated endotoxin levels. These contaminants can cause inflammation, tissue irritation, delayed healing, fever, low blood pressure, and in severe cases, septic shock.
- Check if you have Puracol (MSC8522, Lot P2090) or Puracol Plus (MSC8622EP, Lot PL2107) dressings
- Stop using affected dressings immediately
- Contact your healthcare provider or wound care specialist about replacement dressings
- Report any adverse effects to the FDA MedWatch program or call 1-888-SAFEMED
Hazard
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Sold states
Domestic distribution nationwide US. International distribution to Mexico and Panama.
Affected count
106,621 US; 2,350 OUS
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2026More Medline Industries, LP recalls
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