CLASS II Device recall · Reported 3 Jul 2019 · FDA Enforcement Report
Thermo Scientific General Purpose Dynamic Bath Precision GP Bath recalled
Thermo Fisher Scientific (Asheville) is recalling Thermo Scientific General Purpose Dynamic Bath Precision GP Bath, distributed in California, Georgia, Kentucky, Pennsylvania. The recall was initiated on 2 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1868-2019
- FDA event ID
- 82903
- Recalling firm
- Thermo Fisher Scientific (Asheville), Marietta, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2019
- FDA classified
- 21 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 2 Apr 2019 | Recall initiated by company | |
| 21 Jun 2019 | Classified by FDA | +80 days |
| 3 Jul 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
Where it was distributed
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
Questions about this recall
Why was it recalled?
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Which lots are affected?
Serial Numbers: 300246811 300246812 300246814 300246815 300247403 300247404 300247406 300247407 300247409 300247789 300247791 300247792
Where was it sold?
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 82903More recalls from Thermo Fisher Scientific (Asheville)
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