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Cincinnati Sub-Zero Products, Inc.

United StatesFDA applicant, unverified

Devices
12
FDA recalls
23

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cincinnati Sub-Zero Products, Inc. makes

The company manufactures medical temperature management systems for therapeutic hypothermia and hyperthermia, including active cooling and heating devices like the Hemotherm Model 400CE and Norm-O-Temp hyperthermia system with blankets. It also produces disposable temperature probes, esophageal/rectal probes, and warming units such as the Warm Air Model 135 system and Blanketrol II hypothermia management system.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

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Rows 1-12 of 12

FDA recalls23

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 23 recalls initiated by Cincinnati Sub-Zero Products, Inc., the earliest on 2004-11-05 and the most recent on 2017-11-27. By recorded status: 23 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 2
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

21 initiated before 2017

Showing the 10 most recent of 23 recalls.

  • 2017

    • 27 Nov 2017 Z-0629-2018 Class II Terminated Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure. Distribution: US Nationwide Distribution Submission number: K122813
    • 9 Mar 2017 Z-1825-2017 Class II Terminated Improperly rated fuses were used in the manufacture of the device. Distribution: Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY,…
      Full distribution text Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.
      Submission number: K122813

  • 2016

    • 7 Nov 2016 Z-0654-2017 Class II Terminated The device may not maintain water flow or temperature control. Distribution: US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC. Submission number: K122813

  • 2015

    • 7 Jan 2015 Z-1129-2015 Class II Terminated Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. Distribution: Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL. Submission numbers: K843146, K902269

  • 2014

    • 8 Jan 2014 Z-1679-2014 Class II Terminated The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but Distribution: The product was distributed to one customer in MI, and internationally (Taiwan) Submission number: K110104

  • 2013

    • 3 Sep 2013 Z-2209-2013 Class II Terminated 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. Distribution: Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN,…
      Full distribution text Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM.
      Submission number: K101589
    • 15 May 2013 Z-0443-2014 Class II Terminated During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer. Distribution: Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally…
      Full distribution text Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.

  • 2012

    • 3 Feb 2012 Z-1656-2012 Not yet classified Terminated Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori Distribution: AL, AR. AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL,K IN,, KS, LA, MA, MD, MI, MN, MO, NC, NE, NM, NY, OH, OK, OR, PA, RI,…
      Full distribution text AL, AR. AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL,K IN,, KS, LA, MA, MD, MI, MN, MO, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI

  • 2011

    • 27 Oct 2011 Z-0969-2012 Unclassified (pre-2012) Terminated The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution. Distribution: Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.
    • 27 Oct 2011 Z-0970-2012 Unclassified (pre-2012) Terminated The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution. Distribution: Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.
Show all 23 recalls

  • 2011

    • 26 Sep 2011 Z-0372-2012 Unclassified (pre-2012) Terminated Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error. Distribution: Nationwide distribution and Canada. Submission number: K072621
    • 20 Jul 2011 Z-3119-2011 Unclassified (pre-2012) Terminated Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. Distribution: Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC,…
      Full distribution text Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
      Submission number: K101148
    • 1 Jun 2011 Z-2888-2011 Unclassified (pre-2012) Terminated Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket. Distribution: Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador,…
      Full distribution text Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.
      Submission number: K101148
    • 19 May 2011 Z-2800-2011 Unclassified (pre-2012) Terminated A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir 134 device's Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit. Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA,…
      Full distribution text Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the country of Canada.
    • 2 May 2011 Z-2720-2011 Unclassified (pre-2012) Terminated The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use. Distribution: Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA)…
      Full distribution text Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.
      Submission number: K811742
    • 2 May 2011 Z-2721-2011 Unclassified (pre-2012) Terminated The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use. Distribution: Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA)…
      Full distribution text Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.
      Submission number: K811742

  • 2010

    • 18 Oct 2010 Z-1817-2011 Unclassified (pre-2012) Terminated The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations. Distribution: Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
      Full distribution text Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.
      Submission number: K101589

  • 2009

    • 14 Nov 2009 Z-0781-2010 Unclassified (pre-2012) Terminated Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO,…
      Full distribution text Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
      Submission number: K942599
    • 14 Nov 2009 Z-0782-2010 Unclassified (pre-2012) Terminated Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. Distribution: Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO,…
      Full distribution text Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
    • 16 Feb 2009 Z-0035-2010 Unclassified (pre-2012) Terminated The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit. Distribution: Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT,…
      Full distribution text Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.
      Submission number: K942599

  • 2005

    • 18 Jan 2005 Z-0670-05 Unclassified (pre-2012) Terminated There is the potential that the power switch assembly can dislodge from the cabinet during use. Distribution: The devices were distributed throughout the United States.
    • 18 Jan 2005 Z-0671-05 Unclassified (pre-2012) Terminated There is the potential that the power switch assembly can dislodge from the cabinet during use. Distribution: The product was distributed to hospitals throughout the United States. Submission number: K843146

  • 2004

    • 5 Nov 2004 Z-0374-05 Unclassified (pre-2012) Terminated Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device. Distribution: The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan,…
      Full distribution text The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
      Submission number: K942599

Frequently asked questions

How many devices does Cincinnati Sub-Zero Products, Inc. have in the registry?

The registry currently lists 12 devices for Cincinnati Sub-Zero Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cincinnati Sub-Zero Products, Inc.'s devices?

Among its 12 most recently registered devices, Cincinnati Sub-Zero Products, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Cincinnati Sub-Zero Products, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Cincinnati Sub-Zero Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cincinnati Sub-Zero Products, Inc.?

FDA recall records list 23 recalls initiated by Cincinnati Sub-Zero Products, Inc., the most recent initiated on 27 Nov 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Cincinnati Sub-Zero Products, Inc. in the registry?

The most recently registered devices listed for Cincinnati Sub-Zero Products, Inc. include HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM, NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS, WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS and DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES.

Generated automatically from registry data and not verified by a human reviewer.