Food, drugs, devices › Cenorin, LLC
Device recall: ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer fo
FDA enforcement event 77637 is a device recall by Cenorin, LLC of Kent, WA, initiated 7 Jun 2017 and classified Class II, with 3 product records.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 2 May 2018. 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
"Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn."
Distribution
"Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3032-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices | 34 units | Class II | Terminated | 23 Aug 2017 |
| Z-3033-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices | 43 units | Class II | Terminated | 23 Aug 2017 |
| Z-3034-2017 | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices | 18 units | Class II | Terminated | 23 Aug 2017 |
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 |
| 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 |
| 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: "Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn."
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) Internationally to Japan, Hong Kong, Brunei, and Israel"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 May 2018. "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.