Food, drugs, devices › Cenorin, LLC
Device recall: HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approxima
FDA enforcement event 68237 is a device recall by Cenorin, LLC of Kent, WA, initiated 24 Apr 2014 and classified Class II, with 1 product record.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 30 Jun 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
"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."
Distribution
"Distribution USA Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1729-2014 | 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… | 25 HLD systems | Class II | Terminated | 18 Jun 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 Jan 2013 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
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: "Distribution USA Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 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.