Agency classClass IIOur severity:High FDA (Devices)·Z-1871-2019·Announced 2019-07-03

Thermo Scientific Dual GP Bath Recalled for Assembly Error

Thermo Fisher Scientific is recalling four Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the set point.

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 (medical device) where the malfunction could cause fluid temperatures to exceed set points, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Thermo Fisher Scientific (Asheville) LLC is recalling four units of the Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath, Model Number TSGP15D. The recall involves specific serial numbers: 300246816, 300246817, 300247411, and 300247412.

The recall is being conducted because the product may have been assembled incorrectly. This assembly error can cause the bath to malfunction, potentially raising the temperature of the fluid in the reservoir above the temperature set point selected by the user.

The affected units were distributed in California, Georgia, Kentucky, and Pennsylvania, as well as in Canada, China, Germany, Japan, New Zealand, and Australia. Users should stop using the affected units and contact the manufacturer for instructions on repair or replacement.

The recalled product

Product: Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
Manufacturer: Thermo Fisher Scientific (Asheville) LLC
Category: Medical Device — Laboratory Equipment
Hazard: overheating
malfunction
Affected units: 4

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 (1)

Serial Numbers: 300246816 300246817 300247411 300247412

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 9 recalled by Thermo Fisher Scientific (Asheville) 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 9 products in this recall →

Same manufacturer · Thermo Fisher Scientific (Asheville) LLC

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Same hazard · overheating