Z-1497-2011

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

Name: Z-1497-2011 High Viscosity Dermabond ProPen 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 High Viscosity Dermabond ProPen 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-1497-2011
Status: Terminated
Initiated: 2011-02-02
Posted: 2011-03-02
Terminated: 2012-11-07
Recalling firm: Ethicon, Inc
Product: High Viscosity Dermabond ProPen 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: 725,722 each (total)
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 Product Code Lot # Product Expiration Date DPP6 CJP639 7/31/2012 DPP6 CJR201 7/31/2012 DPP6 CKB291 8/31/2012 DPP6 CKB882 8/31/2012 DPP6 CKE426 8/31/2012 DPP6 CKE893 8/31/2012 DPP6 CKP445 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)