Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Recall Insight

This FDA Devices action (record #Z-0001-2021) was formally reported on October 7, 2020, with the manufacturer initiating the action on August 12, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien, LP is listed as the recalling firm, operating out of North Haven, CT. Federal records indicate 900,007 total units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and Global Distribution.. 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 6 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.