Class II — Potential Health Hazard

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...

Date: June 16, 2016
Company: Halyard Health, Inc
Status: Terminated
Source: FDA (Device)

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

Affected (8 states)Not affected

About Halyard Health, Inc

Halyard Health, Inc has 48 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report