Organogenesis, Inc. Apligraf (Graftskin) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Apligraf (Graftskin)
Brand
Organogenesis, Inc.
Lot Codes / Batch Numbers
LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82, 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198
Products Sold
LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198
Organogenesis, Inc. is recalling Apligraf (Graftskin) due to Product pH out of specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product pH out of specification
Recommended Action
Per FDA guidance
Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.
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