Ligamax 5 mm Endoscopic Multiple Clip Applier

Recall Insight

This FDA Devices action (record #Z-0656-2020) was formally reported on December 18, 2019, with the manufacturer initiating the action on November 7, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Ethicon Endo-Surgery Inc is listed as the recalling firm, operating out of Blue Ash, OH. Federal records indicate 48,428 units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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 C…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.