FDA Medical Device Recalls (openFDA)
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 number
- Z-0181-2010
- Recalling firm
- Organogenesis, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-09-27
- Posted
- 2009-11-12
- Terminated
- 2010-03-31
- Reason
- Unit contaminated with Staphylococcus epidermidis
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 60 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.
- 510(k) numbers
- not on file
- PMA numbers
- ["P950032"]
- Product code
- MGR
- Firm FEI
- 1000148471
- Firm city
- Canton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28