Food, drugs, devices › Cenorin, LLC
Device recall: HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Cenorin, LLC (Kent, WA) initiated this device recall on 24 Jan 2013; FDA lists 1 product record under event 68580, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 10 Feb 2015. Initiation: voluntary: firm initiated. Cenorin, LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cenorin, LLC, Kent, WA.
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."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1995-2014 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | 25 HLD systems | Class II | Terminated | 16 Jul 2014 |
Context
Other enforcement events for Cenorin, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Apr 2018 | HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610H | Device | Class II | 1 |
| 7 Jun 2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer fo | Device | Class II | 3 |
| 24 Apr 2014 | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approxima | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 hot water."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Feb 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.