Ethicon STRATAFIX Spiral PDS Plus Device Recall: Potential Barb Non-Engagement
Ethicon recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device due to potential barb non-engagement. Affected units sold from MO-4 date. Contact Ethicon for details.
Recall notice
Potential for barb non-engagement.
Contact the company
What happened, in plain English
Ethicon is recalling a type of surgical device called STRATAFIX Spiral PDS Plus that may not engage properly with tissue. This could lead to the device failing during surgery, potentially causing complications for patients. Read more at govinfonow.com/recall/51606-ethicon-stratafix-spiral-pds-plus-device-recall-potential-barb-non.
Source Summary by GovInfoNow · govinfonow.com/recall/51606-ethicon-stratafix-spiral-pds-plus-device-recall-potential-barb-non · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2605-2025
Cite this page
“Ethicon STRATAFIX Spiral PDS Plus Device Recall: Potential Barb Non-Engagement.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51606-ethicon-stratafix-spiral-pds-plus-device-recall-potential-barb-non. Based on FDA recall #Z-2605-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2605-2025%22&limit=1).
Why it’s dangerous
The device's barbs may not securely attach to tissue during surgery. If the barbs fail to engage, the device could slip out of place, potentially causing tissue damage or requiring additional surgical intervention.
Who’s affected
Surgical professionals and patients who use this device during procedures. Those with the specific product code or lot number are most at risk.
How to tell if you have this one
Check for product code SXPP2B400-11 or lot number 104DBB. The device was sold with a date of manufacture (D/A) of MO-4.
- Brand
Ethicon- Product
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4)- Category
Medical device
What to do — step by step
Check Product Details
Look for product code SXPP2B400-11 or lot number 104DBB on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Illinois, Indiana, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Mexico, North Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2605-2025 (August 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2605-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.