Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller Recalled by Hologic, Inc Due to NovaSure Radiofrequency Control Units may not meet a...
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 Hologic, Inc directly.
Affected Products
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Quantity: 93 units
Why Was This Recalled?
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report