Warning
Integra LifeSciences Corp. (NeuroSciences) Recalls Cytal Wound Matrix 2-Layer 5x5 cm
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1816-2026Medical Device
Integra LifeSciences Corp. (NeuroSciences) Recalls Cytal Wound Matrix 2-Layer 5x5 cm
Integra LifeSciences Corp. (NeuroSciences) · Class II — Moderate Risk
Product Description
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Reason for Recall
Increased rate of out-of-specification endotoxin results.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Integra LifeSciences Corp. (NeuroSciences) initiated the recall on March 19, 2026 affecting 148 units. Increased rate of out-of-specification endotoxin results. The product was distributed in 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. Consumers should check their purchases and discontinue use of any affected product. Contact Integra LifeSciences Corp. (NeuroSciences) for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.