Class II — Cenorin, LLC
| Recalling firm | CENORIN |
|---|---|
| Registered facility | CENORIN, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. |
| Quantity | 25 HLD systems |
| Distribution | Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan. |
| Initiated | 2013-01-24 |
| Classified | 2014-07-06 |
| Terminated | 2015-02-10 |
| Recall number | Z-1995-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cenorin, LLC (Z-1995-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68580/
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