Shelhigh Inc EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.
Brand
Shelhigh Inc
Lot Codes / Batch Numbers
Lot#, Catalog #, Description: 030911-NR, ENR-20210, 2CM X 10CM, 030911-NR, ENR-20404, 4CM X 4CM, 030911-NR, ENR-20506, 5CM X 6CM, 030808-NR, ENR-20610, 6CM X 10CM, 030811-NR, ENR-20610, 6CM X 10CM, 030911-NR, ENR-21012, 10CM X 12CM, 030924-NR, ENR-21012, 10CM X 12CM, 031027-NR, ENR-21212, 12CM Diameter.
Products Sold
Lot#, Catalog #, Description: 030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.
Shelhigh Inc is recalling EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, an due to The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
Recommended Action
Per FDA guidance
Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
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