Lower riskMedical device recall · FDA · Published March 8, 2024
Ethicon STRATAFIX Spiral Monocryl Plus: Sterility Compromised During Shipping
Ethicon recalls STRATAFIX Spiral Monocryl Plus devices that may have lost sterility during shipping, risking infection. Affected units were shipped with foil pouches that degraded due to environmental exposure.
“Ethicon STRATAFIX Spiral Monocryl Plus: Sterility Compromised During Shipping.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55950-ethicon-stratafix-spiral-monocryl-plus-sterility-compromised-during-shipping. Based on FDA recall #Z-1533-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2024%22&limit=1).
Ethicon, Inc. recalled STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device units due to compromised sterility, the FDA said on March 8, 2024. Owners should contact Ethicon for a replacement.
How to tell if you have it
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD
UPC 10705031464285
UPC 30705031464289
The hazard
The devices were degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility.
Context
Ethicon has 25 other recalls on record since August 17, 2017. Other recent recalls of similar products include Ethicon Monocryl Sutures Recall (October 8, 2024), Ethicon Coated VICRYL Suture Recall (September 25, 2024), and Ethicon VICRYL Suture Recall (May 10, 2024). Other recent recalls of similar products include Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), Intuitive Surgical da Vinci SP Access Port Kit Recall (December 15, 2025), and Karl Storz Flexible Hystero-Fiberscope Kits (May 21, 2026).
How to tell if you have this one
Check for product code SXMP2B412 or UDI/GTIN 30705031464289 (box) and 10705031464285 (pouch). The lot number SHBAEC with an expiration date of June 30, 2024, indicates the affected batch.
Brand
Ethicon
Product
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for product code SXMP2B412 or UDI/GTIN 30705031464289 (box) and 10705031464285 (pouch) on the packaging.
Where it went and when
Where it was distributed
Distributed in 9 states.
Listed by the agency
Not listed
FDA distribution: “CO GA IA MI NJ NY NY PA SC WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Georgia, Iowa, Michigan, New Jersey, New York, Pennsylvania, South Carolina, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1533-2024 (March 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1533-2024 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.