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.

Recall Insight

This FDA Devices action (record #Z-1094-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on January 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Hologic, Inc is listed as the recalling firm, operating out of Marlborough, MA. Federal records indicate 93 units units are affected.

The documented reason for this recall is: NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.