Cincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error
Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (verbiage added back to manuals) without reporting any injuries, illnesses, or specific functional defects. This aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
Cincinnati Sub-Zero Products Inc. is recalling the Blanketrol III Operations (57201-N) and Operations & Technical (56201-Q) manuals. The recall involves 396 units of the 115V model and 385 units of the 230V model, which were distributed worldwide, including in the United States and numerous international locations.
During a label review, the company discovered that specific verbiage was added back into the manuals during Engineering Change Notice M111-4260, released on December 29, 2011. This text had previously been removed to clarify the intended use of the device and to align with subsequent 501(K) approval. The presence of this text in the manuals represents a labeling error.
The affected devices are Hyper-Hypothermia devices used to lower or raise a patient's temperature. Users should check their manual version and serial numbers against the recall list provided by the manufacturer. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 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.
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Hazard
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 (20)
- Part number: 86107/06107/6107 (115V)
- Serial #s: 112-3-02021
- 112-3-02102 through 124-3-02783
- 074-3-00388
- 081-3-00489
- 081-3-00493
- 082-3-00511
- 091-3-00935
- 094-3-01261
- 094-3-01265
- 094-3-01272
- 094-3-01304
- 094-3-01308
- 101-3-01384
- 093-3-01045
- 093-3-01046
- 093-3-01069
- 084-3-00775
- 073-3-00315
- 091-3-00918
Distribution
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
- HighCincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems
FDA (Devices) · 2014-06-11
- ModerateCincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10
FDA (Devices) · 2013-12-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02