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.
What this means for you
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
- Hazard
- 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 →Related recalls
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See all →- HighHLD Systems Washer Pasteurizer Recalled for Terminal Block Overheating
FDA (Devices) · 2018-07-04
- HighCenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
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- SevereCenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block
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- ModerateCenorin HLD Systems Model 610 Washer Recalled for Cleaning Fluid Defect
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