# FDA recall Z-2605-2025

> **ETHICON, LLC** · Class II · device recall initiated 2025-08-15.

## 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.

## Reason for recall

Potential for barb non-engagement.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.

## Key facts

- **Recall number:** Z-2605-2025
- **Recalling firm:** ETHICON, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-15
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guaynabo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2025

## Citation

> AI Analytics. FDA recall Z-2605-2025. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-2605-2025. Source: US FDA. Licensed CC0.

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