Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CSA Medical truFreeze System Recalled by CSA Medical Due to An increase in complaint trending for a loss...

Date: November 10, 2014
Company: CSA Medical
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 CSA Medical directly.

Affected Products

CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

Quantity: 46

Why Was This Recalled?

An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

Where Was This Sold?

This product was distributed to 25 states: AR, CA, CO, CT, FL, GA, IL, IN, LA, MD, MA, MI, NJ, NY, NC, OK, PA, RI, SC, TN, TX, UT, VA, WV, DC

Affected (25 states)Not affected

About CSA Medical

CSA Medical has 2 total recalls tracked by RecallDetector.

Related Recalls

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