Recall Weekly
Moderate riskFDA DeviceClass II

Physitemp TH-8 Thermalert thermometer recalled for unreviewed safety

Physitemp Instruments, LLC is recalling TH-8 Thermalert monitoring thermometers and their associated probes. The temperature monitors have not been reviewed for safety and effectiveness for their intended use. The notice reports no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside affected TH-8 units, which are all manufacturing batches distributed between January 19, 2024, and January 19, 2026.
  2. Check that the model is REF TH-8 before setting units aside.
  3. Contact Physitemp Instruments, LLC for next steps; the notice doesn't say how to get a repair, replacement or refund.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp TH-8 Thermalert Monitoring Thermometer REF: TH-8
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 10 products — see all of them.

Details

Units affected
36 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0407-2027

In the FDA's words

Description
Physitemp TH-8 Thermalert Monitoring Thermometer REF: TH-8 Temperature monitors and associated probes have not been reviewed for safety and effectiveness for intended use. Lot Code: All manufacturing batches distributed between January 19, 2024, and 01/19/2026. Distribution: Worldwide - US Nationwide distribution in the states of AR, MA, CA, PA, NY, IN, MD, KS, FL, LA, WA, WI, FL, CT, VA, OH, TX, MN, GA, UT and the countries of Japan, Canada, Australia, China, France, Sweden, England. Affected quantity: 36 units
Hazard
Temperature monitors and associated probes have not been reviewed for safety and effectiveness for intended use.

10 products in this recall

Physitemp temperature monitors and probes recalled, not safety reviewed

Physitemp Instruments is recalling 10 Physitemp temperature monitors and probes, including rectal, esophageal, skin, oral and general-purpose probes and Thermalert monitoring thermometers. The FDA says these devices have not been reviewed for safety and effectiveness for their intended use. The FDA classified the recall as Class II, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

OtherMedical devicesSold nationwideMore from FDA Device