Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Recall Insight

This FDA Devices action (record #Z-1271-2019) was formally reported on May 22, 2019, with the manufacturer initiating the action on April 11, 2019. It is classified under Critical severity (Class I), with a current status of Completed. Ethicon Endo-Surgery Inc is listed as the recalling firm, operating out of Blue Ash, OH. Federal records indicate 434,614 total units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The staplers may have an insufficient firing stroke to break the washer and completely form staples. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, In…. 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.