Z-0565-2008

Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery

Name: Z-0565-2008 Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery
Creator: Ethicon Endo-Surgery Inc
Published: 2007-11-06
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2007-11-06 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242 on 2007-11-06. The reason FDA records is "Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices". 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-0565-2008
Status: Terminated
Initiated: 2007-11-06
Posted: 2008-01-29
Terminated: 2009-12-09
Recalling firm: Ethicon Endo-Surgery Inc
Product: Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
Product code: GDI Dissector, Surgical, General & Plastic Surgery
Reason for recall: Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Endopath sent consignees an Urgent Device Recall notification letter on or about 11/15/07, informing them that the possibility exists that damage to the packaging of this product may have compromised the sterility of the product. The firms were told to examine their inventory, and remove all affected product. All consignees were instructed to complete the Business Reply Form; even if they did not have any product. Recalled products are to be returned to Ethicon for a credit.
Quantity in commerce: 2,844
Distribution: Worldwide, USA including states of AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NV, NY, OH, PA, RI, TN, TX, AND WA, and countries of Austria, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Portugal, Puerto Rico, Republic of Panama, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, and Venezuela.
Product codes and lots: Lot No: D4HZ9Y.

Product code GDI

K984240Class IIEndopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. / cleared 1999-06-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)