FDA Medical Device Recalls (openFDA)
Thermo Fisher Scientific (Asheville) LLC: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
- Recall number
- Z-1865-2019
- Recalling firm
- Thermo Fisher Scientific (Asheville) LLC
- Product
- Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
- Status
- Terminated
- Initiated
- 2019-04-02
- Posted
- not on file
- Terminated
- 2020-07-23
- Reason
- 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.
- Root cause
- Process control
- Action
- Thermo Fisher issued on 4/02/19 via Email notification with attachments to distributors (domestic and foreign) the Urgent Medical Recall Notification Letter with customer response sheet. Recall is to the user level.On May 23, 2019 email followed by a formal written, "Urgent Medical Device Recall Notification Letter" with customer response sheet were sent via US mail to domestic customers. Letters address health risk and action to take: customer service team is prepared to send you a replacement immediately and the necessary materials and instructions for the return of the bath you received initially to the factory. Please call representatives with your original purchase order, company name, and contact information at 866-984-3766 or email the included Recall Customer Response Form.
- Quantity
- 10 units
- Distribution
- CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
- Lot, serial or model codes
- Serial Numbers: 30024679S 300246796 300246797 300246798 300246799 300247393 300247394 30024739S 300247396 3002477S8
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTQ
- Firm FEI
- 1523845
- Firm city
- Marietta
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28