SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

Recall Insight

This FDA Devices action (record #Z-2406-2024) was formally reported on July 24, 2024, with the manufacturer initiating the action on June 11, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ethicon Sarl, a Johnson & Johnson Company is listed as the recalling firm, operating out of Neuchatel. Federal records indicate 450,793 units (65,950 US, 384,843 OUS) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of India and Japan.. 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 2 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.