Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Blanketrol III Recalled by Cincinnati Sub-Zero Products Inc Due to During a label review it was discovered that...
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 Cincinnati Sub-Zero Products Inc directly.
Affected Products
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
Quantity: 115V - 396 units; 230V - 385 units
Why Was This Recalled?
During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.
Where Was This Sold?
This product was distributed to 40 states: AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
About Cincinnati Sub-Zero Products Inc
Cincinnati Sub-Zero Products Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report