FDA Medical Device Recalls (openFDA)
Organogenesis, Inc.: Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
- Recall number
- Z-0675-2008
- Recalling firm
- Organogenesis, Inc.
- Product
- Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
- Status
- Terminated
- Initiated
- 2007-12-26
- Posted
- 2008-01-24
- Terminated
- 2015-05-15
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 177 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A
- 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