Integra LifeSciences Corp. Endura No-React Dural Substitute 2 cm x 10 cm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endura No-React Dural Substitute 2 cm x 10 cm
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Product code: ENR20210: all lots
Products Sold
Product code: ENR20210: all lots
Integra LifeSciences Corp. is recalling Endura No-React Dural Substitute 2 cm x 10 cm due to Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Uni. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t
Recommended Action
Per FDA guidance
On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026