RegWardenFDA facility compliance records
Recall

Class II — Cenorin, LLC

Recalling firmCENORIN
Registered facilityCENORIN, LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThere is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
ProductHLD 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
Quantity14 units
DistributionWorldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
Initiated2018-04-09
Classified2018-06-26
Terminated2019-09-13
Recall numberZ-2288-2018
InitiationVoluntary: 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-2288-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80295/

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