Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

Recall Insight

This FDA Devices action (record #Z-0655-2020) was formally reported on December 18, 2019, with the manufacturer initiating the action on October 18, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. CP Medical Inc is listed as the recalling firm, operating out of Norcross, GA. Federal records indicate 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures 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: Failed to meet USP minimum average value for knot pull (tensile) strength. Distribution data in the federal record shows the product reached: USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE. 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.