NovaSure Impedance Controlled Endometrial Ablation System… — Class II medical device recall Z-1094-2014
Terminated recall by Hologic, Inc, reported 2014-03-05, distributed nationwide. NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
| Recall number | Z-1094-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2014-01-24 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, SE |
| Quantity | 93 units |
| Serial numbers | 33868H13D0, 33869H13D0, 33870H13D0, 33871H13D0, 33872H13D0, 33873H13D0, 33874H13D0, 33875H13D0, 33876H13D0, 33877H13D0, 33878H13D0, 33879H13D0, 33880H13D0, 33881H13D0, 33882H13D0, 33883H13D0, 33884H13D0, 33885H13D0, 33886H13D0, 33888H13D0, 33889H13D0, 33890H13D0, 33891H13D0, 33892H13D0, 33893H13D0 and 68 more |
| Model numbers | 71978-001, RFC2009 |
Product
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.
Reason for recall
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.