Organogenesis, Inc. Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.
Brand
Organogenesis, Inc.
Lot Codes / Batch Numbers
Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.
Products Sold
Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.
Organogenesis, Inc. is recalling Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with stan due to Unit contaminated with Staphylococcus epidermidis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unit contaminated with Staphylococcus epidermidis
Recommended Action
Per FDA guidance
Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm. For further information, contact Organogenesis, Inc. at 1-888-432-5232.
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