Z-1496-2011

Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc

Name: Z-1496-2011 Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc
Creator: Ethicon, Inc.
Published: 2011-02-02
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2011-02-02 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc on 2011-02-02. The reason FDA records is "Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1496-2011
Status: Terminated
Initiated: 2011-02-02
Posted: 2011-03-02
Terminated: 2012-11-07
Recalling firm: Ethicon, Inc
Product: Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code KGX

K813124Class IEthicon* Skin Closure TapeETHICON, Inc. / cleared 1981-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)