Agency classClass IIOur severity:High FDA (Devices)·Z-2288-2018·Announced 2018-07-04

HLD Systems Washer Pasteurizer Recalled for Terminal Block Overheating

Cenorin, LLC is recalling 14 HLD Systems 600 Series Washer/Pasteurizers because a supplier quality issue with terminal blocks may cause overheating, charring, or burning.

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) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Cenorin, LLC is recalling 14 units of the HLD Systems 600 Series Washer/Pasteurizer, specifically Model 610HT in 115V and 230V configurations. The recall is due to a supplier quality issue with the terminal blocks, which may cause the components to overheat, char, and/or burn.

The affected units were distributed worldwide, including nationwide in the United States in the states of California, Florida, Indiana, North Carolina, Nebraska, Utah, and West Virginia, as well as in Malaysia and Taiwan. The specific serial numbers for the recalled units are 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609, and 611610.

Users of these devices should contact Cenorin, LLC for further instructions on how to address the potential safety hazard.

The recalled product

Product: HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Manufacturer: Cenorin, LLC
Category: Medical Device — Washer/Pasteurizer
Hazard: fire
burn-injury
Affected units: 14

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 (13)

Serial Numbers: 611503
611504
611505
611506
611601
611602
611603
611604
611605
611606
611607
611608
611609 & 611610

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Cenorin, LLC

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High
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Same hazard · fire