Agency classClass IIOur severity:High FDA (Devices)·Z-3032-2017·Announced 2017-08-23

Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

Cenorin, LLC is recalling 34 ThermaSure Series 130 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, which aligns with the High severity criteria.

Plain-English summary

Cenorin, LLC is recalling 34 units of the ThermaSure Series 130 Medical Device Dryer, specifically Models 135 and 136. The recall is due to a manufacturing issue that causes the terminal block to overheat, char, and/or burn. The affected units were distributed nationwide in the United States and internationally to Japan, Hong Kong, Brunei, and Israel.

The specific serial numbers for the recalled Model 135 units are 350423, 350424, 351506, 351507, 351512, 351513, 351514, 351516, 351602, 351604, 351605, 351606, 351609, 351611, 351613, 351614, 351615, 351616, 351617, 351618, 351619, 351620, 351621, 351622, 351623, and 351624. The specific serial numbers for the recalled Model 136 units are 361505, 361511, 361515, 361601, 361603, 361607, 361608, and 361612.

Users should check their equipment serial numbers against the list provided. If the unit is affected, they should contact Cenorin, LLC for instructions on how to proceed with the recall.

The recalled product

Product: ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
Manufacturer: Cenorin, LLC
Category: Medical Device — Medical Device Dryer
Hazard: fire
burn-injury
Affected units: 34

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: 350423
350424
351506
351507
351512
351513
351514
351516
351602
351604
351605
351606
351609
351611
351613
351614
351615
351616
351617
351618

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