Integra Lifesciences Corp. (neurosciences): Wound Dressing With Animal-derived Material(s)
Recall Summary Integra LifeSciences is recalling Cytal Wound Matrix 2-Layer 10x15 cm (Product ID: WSM1015), a wound dressing made with animal-derived material, because some units have higher-than-acceptable levels of endotoxin, which are bacterial substances that can trigger harmful immune responses. The product was distributed nationwide across the United States. This recall affects medical facilities and healthcare providers that received this product.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
- Reason
- Increased rate of out-of-specification endotoxin results.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/31600ba1-e9cd-4cb0-b15d-b4fc0a841f6f