CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

Ligaclip¿ Endoscopic Rotating Multiple Clip Applier recalled

Ethicon Endo-Surgery is recalling Ligaclip¿ Endoscopic Rotating Multiple Clip Applier (ER320) M/L, bulk non-sterile, distributed nationwide in the US. The recall was initiated on 12 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCK017, 02, 2016-11 to 2018-03

Quantity recalled10,488

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1777-2013
FDA event ID: 65141
Recalling firm: Ethicon Endo-Surgery, Cincinnati, OH
Classification: Class II
Status: Terminated
Recall initiated: 12 Apr 2013
FDA classified: 19 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

12 Apr 2013	Recall initiated by company
19 Jul 2013	Classified by FDA	+98 days
31 Jul 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Ligaclip¿ Endoscopic Rotating Multiple Clip Applier (ER320) M/L, bulk non-sterile recalled?

Yes. Ethicon Endo-Surgery recalled Ligaclip¿ Endoscopic Rotating Multiple Clip Applier (ER320) M/L, bulk non-sterile on 12 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1777-2013.

Why was it recalled?

Which lots are affected?

CK017, 02, 2016-11 to 2018-03

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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