The Recall Desk
ModerateFDA (Devices)·Z-2605-2025·Announced 2025-10-01

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device recalled

Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential device malfunction (barb non-engagement) that could affect surgical outcomes but presents a theoretical rather than confirmed risk of harm.

Plain-English summary

Ethicon LLC is recalling the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, Product Code SXPP2B400-11, Lot Number 104DBB. The device is used for tissue control during surgical procedures.

The recall is due to potential for barb non-engagement, which could impact the device's intended function. A total of 516 units have been identified.

The affected device was distributed worldwide and within the United States in Arkansas, Arizona, California, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Minnesota, North Carolina, New Hampshire, New Mexico, Texas, Virginia, Washington, and Wisconsin. International distribution includes Singapore and Malaysia. The device is identified by GTIN 10705031464568 (each) or 30705031464562 (box of 12).

Customers who have received this product should contact Ethicon LLC to determine if they have affected units and receive guidance on appropriate actions.

The recalled product

Product
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.
Manufacturer
ETHICON, LLC
Category
Medical Device — Surgical Suture/Tissue Control
Hazard
  • device-malfunction
  • barb-non-engagement

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code: SXPP2B400-11. GTIN: 10705031464568 (each)
  • 30705031464562 (box of 12). Lot Number: 104DBB.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category