Z-1627-2012

The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight...

Name: Z-1627-2012 The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight...
Creator: Ethicon Endo-Surgery Inc
Published: 2012-03-02
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2012-03-02 / Terminated / root cause: supplier

FDA source

Ethicon Endo-Surgery Inc began a recall of The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter -... on 2012-03-02. The reason FDA records is "There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1627-2012
Status: Terminated
Initiated: 2012-03-02
Posted: 2012-05-18
Terminated: 2013-03-22
Recalling firm: Ethicon Endo-Surgery Inc
Product: The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. The ECHELON 60 Endoscopic Linear Cutter Straight, Compact ECHELON 60 Endoscopic Linear Cutter Straight, and the Long ECHELON 60 Endoscopic Linear Cutter Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
Product code: GDW Staple, Implantable
Reason for recall: There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Ethicon Endo-Surgery sent an Urgent Device Recall letter dated March 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have the affected product and to remove the affected product. Fill out the Business Reply Form and fax it to 1-513-337-4138 within 3 business days, even if they do not have the affected product in their inventory. Ethicon will automatically replace any affected product returned by June 29, 2012. Customers were asked to share this information with appropriate staff. If customers should need clinical or product support call 1-800-873-3636, option 6, or contact their local sales representative. For questions regarding this recall call 513-337-7000.
Quantity in commerce: 3120
Distribution: Worldwide Distribution - USA including AL, AR, CA, CO, FL, IA, IL, KS, LA, MD, MO, MS, NC, NM, NY, OH, SC, TX & VA; and the countries of Argentina, Ecuador, Mexico, Australia, Egypt, Singapore, Belgium, Greece, Slovenia, Brazil, India, South Africa, China, Israel, United Arab Emirates, Colombia, Japan & Venezuela.
Product codes and lots: Model # EC60: H44T06, J4A56P, J4A67X, H44T6E, J4A650, J4A762, J4A49A, J4A65N, J4A766, J4A49G, J4A677, J4A76F, J4A567, J4A67D, J4A76L, J4A56F, J4A67H, J4A771; Model # LONG60 lots: H44R8A , H44U3R , H44X17 , J4A55E , J4A64A; Model # SC60: H44R6C, J4A777, J4A58D, J4A77F, J4A58N, J4A78Y, J4A58P.

Product code GDW

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)