The FDA has posted 6 enforcement recalls of wound dressing with animal-derived material(s) devices since 2025, none of them Class I (most serious). Most recent report: Apr 22, 2026.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
Increased rate of out-of-specification endotoxin results.
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.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Wound Dressing With Animal-Derived Material(S)”). Informational only — verify against the FDA before acting.