Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BULKAMID Recalled by Axonics Modulation Technologies, Inc. Due to Lack of Sterility Assurance; needle in procedure pack...
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 Axonics Modulation Technologies, Inc. directly.
Affected Products
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Quantity: 2,702 units
Why Was This Recalled?
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc. 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