Organogenesis, Inc. Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
Brand
Organogenesis, Inc.
Lot Codes / Batch Numbers
Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
Products Sold
Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
Organogenesis, Inc. is recalling Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachuse due to Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminar. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.
Recommended Action
Per FDA guidance
On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, "Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc." Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.
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