Health & Personal Care
HIGH
FDA DEVICE
Ethicon Stratafix PDS Plus Recall 516 Units for Barb Non-Engagement (2025)
Ethicon recalled 516 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Devices sold worldwide through healthcare providers, including 18 U.S. states and Singapore and Malaysia. The defect is potential barb non-engagement that could compromise tissue control. Clinicians and patients should stop using the device immediately and follow recall instructions from Ethicon.
Ethicon
Potential for