CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report

Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled

Ethicon is recalling Stratafix Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI, distributed nationwide in the US. The recall was initiated on 15 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.

Quantity recalled516 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2605-2025
FDA event ID: 97471
Recalling firm: Ethicon, Guaynabo, PR
Classification: Class II
Status: Ongoing
Recall initiated: 15 Aug 2025
FDA classified: 19 Sep 2025
Reported: 1 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Aug 2025	Recall initiated by company
19 Sep 2025	Classified by FDA	+35 days
1 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for barb non-engagement.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas Arizona California Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri North Carolina New Hampshire New Mexico Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Potential for barb non-engagement.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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