CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report

HLD Systems 600 Series Washer/Pasteurizer recalled by Cenorin

Cenorin is recalling HLD Systems 600 Series Washer/Pasteurizer, distributed nationwide in the US. The recall was initiated on 9 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2288-2018
FDA event ID: 80295
Recalling firm: Cenorin, Kent, WA
Classification: Class II
Status: Terminated
Recall initiated: 9 Apr 2018
FDA classified: 26 Jun 2018
Reported: 4 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Processing Deviation
Device type: Other Medical Devices

Timeline

9 Apr 2018	Recall initiated by company
26 Jun 2018	Classified by FDA	+78 days
4 Jul 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

Nationwide California Florida Indiana North Carolina Nebraska Utah West Virginia

Questions about this recall

Is HLD Systems 600 Series Washer/Pasteurizer recalled?

Yes. Cenorin recalled HLD Systems 600 Series Washer/Pasteurizer on 9 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2288-2018.

Why was it recalled?

There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.

Which lots are affected?

Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610

Where was it sold?

Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cenorin

All 6

Reported	Class	Recall	Company	Reason	Where
23 Aug 2017Device	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
23 Aug 2017Device	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
23 Aug 2017Device	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
16 Jul 2014Device	CLASS II	HLD System recalled by Cenorin	Cenorin	Temperature Abuse	Nationwide
18 Jun 2014Device	CLASS II	HLD Systems recalled by Cenorin	Cenorin	Temperature Abuse	Nationwide

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