FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
- Recall number
- Z-1496-2011
- Recalling firm
- Ethicon, Inc.
- Product
- Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
- Status
- Terminated
- Initiated
- 2011-02-02
- Posted
- 2011-03-02
- Terminated
- 2012-11-07
- Reason
- Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
- Root cause
- Nonconforming Material/Component
- Action
- Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.
- Quantity
- 725,772
- Distribution
- Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, ireland, Israel, italy, Japan, Korea, Lithuania, Luxembourg, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Palestine, Puerto Rico, Reunion, Russia, Senegal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Ukraine, and Venezuela.
- Lot, serial or model codes
- Product code Lot # Exp. Date DHV12 CJE222 7/31/2012 DHV12 CJP430 7/31/2012 DHV12 CJR302 7/31/2012 DHV12 CJR488 7/31/2012 DHV12 CJR604 7/31/2012 DHV12 CKB001 7/31/2012 DHV12 CKB157 8/31/2012 DHV12 CKB231 8/31/2012 DHV12 CKB492 8/31/2012 DHV12 CKB584 8/31/2012 DHV12 CKB681 8/31/2012 DHV12 CKB820 8/31/2012 DHV12 CKB966 8/31/2012 DHV12 CKE195 8/31/2012 DHV12 CKE335 8/31/2012 DHV12 CKE336 8/31/2012 DHV12 CKE655 8/31/2012 DHV12 CKE842 8/31/2012 DHV12 CKP038 8/31/2012 DHV12 CKP201 8/31/2012 DHV12 CKP358 8/31/2012
- 510(k) numbers
- ["K813124"]
- PMA numbers
- ["P960052"]
- Product code
- KGX
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- 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