Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053

Recall Insight

This FDA Devices action (record #Z-2543-2017) was formally reported on June 21, 2017, with the manufacturer initiating the action on May 3, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic is listed as the recalling firm, operating out of North Haven, CT. Federal records indicate 478,465 (total for all products) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.. 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 9 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.