Medical device recalls Moderate risk

Medline Industries, LP recalls Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,CO…

Recall date
February 10, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1650-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
Domestic distribution nationwide US. International distribution to Mexico and Panama.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

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