Z-1777-2013Class II

LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile

Name: Z-1777-2013 LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile
Creator: Ethicon Endo-Surgery Inc
Published: 2013-04-12
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2013-04-12 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is... on 2013-04-12. FDA classified it as Class II and gives the reason as "Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1777-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Posted: 2013-07-19
Terminated: 2014-05-01
Recalling firm: Ethicon Endo-Surgery Inc
Product: LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique.
Product code: GDO Applier, Surgical, Clip
Reason for recall: Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
FDA root cause: Under Investigation by firm
Action: Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
Quantity in commerce: 10,488
Distribution: Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.
Product codes and lots: CK017, 02, 2016-11 to 2018-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1777-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19
Z-1776-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19
Z-1777-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code GDO

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)