Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coolife Sinergy Radiofrequency Kit Recalled by Halyard Health, Inc Due to Mismatch between the length of the RF electrode...
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 Halyard Health, Inc directly.
Affected Products
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Quantity: 51 kits
Why Was This Recalled?
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Where Was This Sold?
This product was distributed to 8 states: CT, IL, MA, MI, NV, NH, NC, TX
About Halyard Health, Inc
Halyard Health, Inc has 48 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report