HLD Systems 600 Series Washer/Pasteurizer — Class II medical device recall Z-2288-2018
Terminated recall by Cenorin, LLC, reported 2018-07-04, distributed nationwide. There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, cha
| Recall number | Z-2288-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cenorin, LLC, Kent, WA, United States |
| Recall initiated | 2018-04-09 |
| Classified | 2018-06-26 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2019-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | MY, TW |
| Quantity | 14 units |
| Reason classes | device malfunction |
| Serial numbers | 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609, 611610 |
| Model numbers | 115V, 230V, 610HT |
Product
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Reason for recall
There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
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-2288-2018. 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.