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Cenorin, LLC

United Statesfrom the FDA registration address FDA FEI 3004153171

Devices
1
Registrations
FDA
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Cenorin, LLC makes

Cenorin, LLC manufactures washer-pasteurizers and high-level disinfectors, specifically the Cenorin 610 and Cenorin 610HT models, which are designed for cleaning and disinfecting medical equipment.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

Company details

FDA FEI number
3004153171
Address
6324 S 199th Pl Ste 107, KENT, WA, 98032

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by Cenorin, LLC, the earliest on 2006-12-21 and the most recent on 2018-04-09. By recorded status: 13 terminated. The reasons filed fall into these groups: electrical or power 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 3
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

9 initiated before 2017

Showing the 10 most recent of 13 recalls.

  • 2018

    • 9 Apr 2018 Z-2288-2018 Class II Terminated There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. Distribution: Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and…
      Full distribution text Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

  • 2017

    • 7 Jun 2017 Z-3032-2017 Class II Terminated Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. Distribution: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
    • 7 Jun 2017 Z-3033-2017 Class II Terminated Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. Distribution: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel
    • 7 Jun 2017 Z-3034-2017 Class II Terminated Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn. Distribution: Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

  • 2014

    • 24 Apr 2014 Z-1729-2014 Class II Terminated Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction. Distribution: Distribution USA Nationwide

  • 2013

    • 24 Jan 2013 Z-1995-2014 Class II Terminated The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water. Distribution: Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay…
      Full distribution text Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.

  • 2010

    • 7 Jun 2010 Z-0036-2011 Unclassified (pre-2012) Terminated The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized with enough wat Distribution: Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
    • 7 Jun 2010 Z-0037-2011 Unclassified (pre-2012) Terminated The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized Distribution: Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
    • 7 Jun 2010 Z-0038-2011 Unclassified (pre-2012) Terminated The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized Distribution: Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
    • 7 Jun 2010 Z-0039-2011 Unclassified (pre-2012) Terminated The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. It could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized Distribution: Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
Show all 13 recalls

  • 2006

    • 21 Dec 2006 Z-0711-2007 Unclassified (pre-2012) Terminated Potential for user to receive an electrical shock. Distribution: Worldwide.
    • 21 Dec 2006 Z-0712-2007 Unclassified (pre-2012) Terminated Potential for user to receive an electrical shock. Distribution: Worldwide.
    • 21 Dec 2006 Z-0713-2007 Unclassified (pre-2012) Terminated Potential for user to receive an electrical shock. Distribution: Worldwide.

Frequently asked questions

How many devices does Cenorin, LLC have in the registry?

The registry currently lists 1 device for Cenorin, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cenorin, LLC's devices?

Among its 1 most recently registered device, Cenorin, LLC has devices listed in FDA 510(k) (1 device).

What risk classes do Cenorin, LLC's devices fall under?

Among its 1 most recently registered device, the classes recorded for Cenorin, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cenorin, LLC?

FDA recall records list 13 recalls initiated by Cenorin, LLC, the most recent initiated on 9 Apr 2018. 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 Cenorin, LLC in the registry?

The most recently registered devices listed for Cenorin, LLC include Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector.

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