Z-1995-2014Class II

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

Name: Z-1995-2014 HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer
Creator: Cenorin, LLC
Published: 2013-01-24
License: https://open.fda.gov/license/

Cenorin, LLC / initiated 2013-01-24 / Terminated / root cause: design

FDA source

Cenorin, LLC began a recall of HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer on 2013-01-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1995-2014
Classification: Class II
Status: Terminated
Initiated: 2013-01-24
Posted: 2014-07-06
Terminated: 2015-02-10
Recalling firm: Cenorin, LLC
Product: HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Product code: LDS Device, Pasteurization, Hot Water
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.
Root cause tag: design
FDA root cause: Device Design
Action: Cenorin sent a Notification letter dated December 18, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated: Cenorin has developed an upgrade to mitigate this issue as well as provide additional process control and system monitoring benefits. Cenorin included a Return Response form with the recall letter to be completed and return. For questions contact HLD Systems Sales Representative for questions.
Quantity in commerce: 25 HLD systems
Distribution: Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1995-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1995-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-06

Product code LDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)