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Recall Observatory FDA recall evidence

Device product

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

Z-1650-2026

February 10, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98484
Status
Ongoing
Classification
Class II
Quantity
106,621 US; 2,350 OUS
Official record key
device-enforcement:Z-1650-2026

Official wording

Reason: 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.

Code information: MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107

Distribution pattern: Domestic distribution nationwide US. International distribution to Mexico and Panama.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.