Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Recalled by ETHICON, LLC Due to Potential for barb non-engagement.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ETHICON, LLC directly.
Affected Products
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
Quantity: 516 units
Why Was This Recalled?
Potential for barb non-engagement.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ETHICON, LLC
ETHICON, LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report