CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report

HLD System recalled by Cenorin

Cenorin is recalling HLD System, distributed nationwide in the US. The recall was initiated on 24 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.

Quantity recalled25 HLD systems

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-1995-2014
FDA event ID: 68580
Recalling firm: Cenorin, Kent, WA
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2013
FDA classified: 6 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

24 Jan 2013	Recall initiated by company
6 Jul 2014	Classified by FDA	+528 days
16 Jul 2014	Published in enforcement report	+10 days

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

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Where it was distributed

Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.

Nationwide California Delaware Florida Massachusetts Michigan New York Pennsylvania Texas Utah Washington Wisconsin

Questions about this recall

Is HLD System recalled?

Yes. Cenorin recalled HLD System on 24 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1995-2014.

Why was it recalled?

Which lots are affected?

610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.

Where was it sold?

Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay 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
4 Jul 2018Device	CLASS II	HLD Systems 600 Series Washer/Pasteurizer recalled by Cenorin	Cenorin	Processing Deviation	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
23 Aug 2017Device	CLASS II	ThermaSure(TM), a Cenorin(TM) product recalled	Cenorin	Other	Nationwide
18 Jun 2014Device	CLASS II	HLD Systems recalled by Cenorin	Cenorin	Temperature Abuse	Nationwide

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