ETHICON recalled 516 units of the STRATAFIX Spiral PDS Plus device on August 15, 2025. The recall follows reports of potential barb non-engagement that could affect surgical procedures. Healthcare providers and patients must stop using the device immediately.
Potential for barb non-engagement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ETHICON, LLC or your healthcare provider for instructions. Notification method: Letter
The recalled product is the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, Product Code SXPP2B400-11. It was distributed in the U.S. states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI, and in Singapore and Malaysia.
The recall warns of potential barb non-engagement, which can compromise surgical procedures. This defect poses a high hazard level and could lead to complications during surgery.
No specific incidents related to injuries or complications have been reported so far. The hazard level is classified as high due to the potential risk during surgical applications.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by ETHICON, LLC or contact your healthcare provider for further instructions.
For more information, contact ETHICON, LLC. Visit the FDA recall page for additional details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2605-2025.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.