HLD System — Class II medical device recall Z-1995-2014
Terminated recall by Cenorin, LLC, reported 2014-07-16, distributed nationwide. The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. Th
| Recall number | Z-1995-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cenorin, LLC, Kent, WA, United States |
| Recall initiated | 2013-01-24 |
| Classified | 2014-07-06 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW, UY |
| Quantity | 25 hld |
| Model numbers | 610 |
Product
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1995-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.