Ethicon Endo-Surgery Inc recalls Ligamax 5 mm Endoscopic Multiple Clip Applier

Recall date

November 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0656-2020

FDA classification

Class II

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SL…

Why it was recalled

A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ligamax 5 mm Endoscopic Multiple Clip Applier