Device recall: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
Class II FDA enforcement event 82903. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Thermo Fisher Scientific (Asheville) LLC started this device recall on 2 Apr 2019. The firm address in the FDA record is in Marietta, OH. FDA put the recall in Class II. FDA event 82903 has 9 product records. The first FDA enforcement report date is 3 Jul 2019. The record gives the status Terminated, with the termination date 23 Jul 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
Recalling firm
Thermo Fisher Scientific (Asheville) LLC, Marietta, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1865-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05 | 10 units | Class II | Terminated | 3 Jul 2019 |
| Z-1866-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10 | 5 units | Class II | Terminated | 3 Jul 2019 |
| Z-1867-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20 | 1 unit | Class II | Terminated | 3 Jul 2019 |
| Z-1868-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10 | 12 units | Class II | Terminated | 3 Jul 2019 |
| Z-1869-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20 | 4 units | Class II | Terminated | 3 Jul 2019 |
| Z-1870-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S | 4 units | Class II | Terminated | 3 Jul 2019 |
| Z-1871-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D | 4 units | Class II | Terminated | 3 Jul 2019 |
| Z-1872-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28 | 3 units | Class II | Terminated | 3 Jul 2019 |
| Z-1873-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05 | 2 units | Class II | Terminated | 3 Jul 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 9Median of the firm: 9
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Nov 2012 | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, Event 64418 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1865-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82903. https://recallregister.com/fda/ii/82903/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia
- What quantity of product is in FDA event 82903?
- The event has 9 product records. The first record gives this quantity:
10 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.