Data Foundry

Medical device recalls 2019

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP… — Class II medical device recall Z-1866-2019

Terminated recall by Thermo Fisher Scientific (Asheville) LLC, reported 2019-07-03, distributed in CA, GA, KY, PA. Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the

Recall numberZ-1866-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmThermo Fisher Scientific (Asheville) LLC, Marietta, OH, United States
Recall initiated2019-04-02
Classified2019-06-21
Reported by FDA2019-07-03
Terminated2020-07-23
DistributedCA, GA, KY, PA
Countries outside the USAU, CA, CN, DE, JP, NZ
Quantity5 units
Reason classesdevice malfunction
Serial numbers300247769, 300247772, 300247773, 300247774, 30024777S
Model numbersFSGPD10

Product

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1866-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.