CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report

HLD Systems recalled by Cenorin

Cenorin is recalling HLD Systems, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 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, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits (61) refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.

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-1729-2014
FDA event ID: 68237
Recalling firm: Cenorin, Kent, WA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2014
FDA classified: 6 Jun 2014
Reported: 18 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

24 Apr 2014	Recall initiated by company
6 Jun 2014	Classified by FDA	+43 days
18 Jun 2014	Published in enforcement report	+12 days

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

Reason for recall

Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.

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 Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product Usage: Usage: This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ¿ 2 F for 30 minutes.

Where it was distributed

Distribution USA Nationwide

Nationwide

Questions about this recall

Is HLD Systems recalled?

Yes. Cenorin recalled HLD Systems on 24 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1729-2014.

Why was it recalled?

Which lots are affected?

610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204. First two digits (61) refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits sequentially numbered as they receive orders.

Where was it sold?

Distribution USA Nationwide

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
16 Jul 2014Device	CLASS II	HLD System recalled by Cenorin	Cenorin	Temperature Abuse	Nationwide

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