Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems
Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to maintain patient temperature, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Cincinnati Sub-Zero Products Inc is recalling seven units of the 115 V Blanketrol II, Model 222S Hyper-Hypothermia System. The recall involves specific serial numbers (133-2-00697 through 133-2-00703) and part number 86165. The device is used to lower, raise, or maintain a patient's temperature through conductive heat transfer.
The recall was initiated because an incorrect voltage component was placed into the devices during manufacturing. This defect may render the device unable to maintain the patient's temperature during cooling mode. While the device will continue to indicate that it is cooling because the compressor will run, the water in the reservoir will return to ambient temperature. The actual water temperature will be displayed on the unit.
The affected products were distributed to one customer in Michigan and internationally to Taiwan. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model Number 222S
- Serial #s: 133-2-00697
- 133-2-00698
- 133-2-00699
- 133-2-00700
- 133-2-00701
- 133-2-00702
- and 133-2-00703:.Part # 86165
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Cincinnati Sub-Zero Products Inc
See all →- HighCincinnati Sub-Zero Recalls Hemotherm CE Heater-Cooling Devices Due to Fuse Defect
FDA (Devices) · 2017-04-26
- HighCincinnati Sub-Zero Hemotherm 400CE Water Flow and Temperature Control Recall
FDA (Devices) · 2016-11-30
- ModerateCincinnati Sub-Zero CT-99 Cold Therapy Pad Recall for Seal Separation
FDA (Devices) · 2015-02-25
- ModerateCincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10
FDA (Devices) · 2013-12-11
- ModerateCincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error
FDA (Devices) · 2013-09-25
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12