Cincinnati Sub-Zero Products LLC, a Gentherm Company Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Brand
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Lot Codes / Batch Numbers
Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)
Products Sold
Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)
Cincinnati Sub-Zero Products LLC, a Gentherm Company is recalling Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is compose due to Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Recommended Action
Per FDA guidance
Gentherm issued URGENT Medical Device Correction, Blanketrol II letters were mailed by USPS starting July 25th and Blanketrol III letters were mailed by USPS starting July 30th. Letters stated problem, health risk and action to take: INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at (513)326-5320. 2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice. 3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to FA2019-004/010@gentherm.com, or mail to: Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241. Questions, call Gentherm Medical Technical Support at 1-888-437-5608 or Stephanie Vocke @ (513)719-3262
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026