Agency classClass IIOur severity:High FDA (Devices)·Z-3033-2017·Announced 2017-08-23

Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

Cenorin, LLC is recalling 43 ThermaSure Series 300 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (fire/burn hazard) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Cenorin, LLC is recalling 43 units of the ThermaSure Series 300 Medical Device Dryer, specifically Models 330 and 340. These forced air dryers are used for medical devices. The recall covers units distributed nationwide in the United States and internationally to Japan, Hong Kong, Brunei, and Israel.

The recall is being conducted because a manufacturing issue causes the terminal block of the dryer unit to overheat, char, and/or burn. This defect can result in the dryer unit not heating properly. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Affected units are identified by specific serial numbers for both Model 330 and Model 340. Users should check their equipment against the provided serial number lists. The source text does not specify the exact corrective action or contact information for consumers, but the recall is managed by Cenorin, LLC.

The recalled product

Product: ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
Manufacturer: Cenorin, LLC
Category: Medical Device — Medical Device Dryer
Hazard: fire
burn-injury
Affected units: 43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

(a) Serial Numbers: 331517
331518
331523
331524
331525
331526
331527
331528
331529
331530
331601
331608
331609
331612
331615
331616
331621
331622
331623
331624

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cenorin, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cenorin, LLC

See all →

High
HLD Systems Washer Pasteurizer Recalled for Terminal Block Overheating
FDA (Devices) · 2018-07-04
High
Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
FDA (Devices) · 2017-08-23
Severe
Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
FDA (Devices) · 2017-08-23
High
Cenorin HLD System Model 610 Recalled for Temperature Sensor Defect
FDA (Devices) · 2014-07-16
Moderate
Cenorin HLD Systems Model 610 Washer Recalled for Cleaning Fluid Defect
FDA (Devices) · 2014-06-18

Same hazard · fire