Z-0418-2020Class II

Blanketrol II Hyper-Hypothermia System, Models 222R and 222S -

Name: Z-0418-2020 Blanketrol II Hyper-Hypothermia System, Models 222R and 222S -
Creator: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Published: 2019-07-02
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2019-07-02 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products LLC, a Gentherm Company began a recall of Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and... on 2019-07-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0418-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Posted: 2019-11-18
Terminated: 2020-06-22
Recalling firm: Gentherm Medical, LLC
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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/[email protected], 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
Quantity in commerce: 3726
Distribution: Worldwide distribution - US Nationwide and countries of Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Oman, Pakistan, Palestine, Panama, Philippines, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Venezuela, Vietnam.
Product codes and lots: Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-18
Z-0418-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-18
Z-0419-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-18

Product code DWJ

K110104Class IIBlanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. / cleared 2011-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)