Medline Industries, LP

Device Recalls (Class II)

← All Device Recalls (Class II)
Class II Z-1650-2026 · 20260401 · Ongoing

Product

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

Reason for Recall

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.

Distribution

Domestic distribution nationwide US. International distribution to Mexico and Panama.

Source: openFDA Enforcement API