Integra LifeSciences Corp Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Brand
Integra LifeSciences Corp
Lot Codes / Batch Numbers
Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
Products Sold
Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
Integra LifeSciences Corp is recalling Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021 due to Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
Recommended Action
Per FDA guidance
Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.
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