Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MiniArc Pro Single incision Sling System Recalled by Astora Due to The lot number on the outer carton label...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Astora directly.
Affected Products
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Quantity: 52
Why Was This Recalled?
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Where Was This Sold?
This product was distributed to 11 states: AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
About Astora
Astora has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report