Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STOCKERT Heater-Cooler System 3T Recalled by Sorin Group USA, Inc. Due to Plastic heat exchanger fibers separating the blood compartment...
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 Sorin Group USA, Inc. directly.
Affected Products
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Quantity: 7,546 units
Why Was This Recalled?
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
Where Was This Sold?
This product was distributed to 49 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC
About Sorin Group USA, Inc.
Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report