Recall Weekly
Moderate riskFDA DeviceClass II

Physitemp SST-1 skin sensor recalled for lack of safety review

Physitemp Instruments is recalling SST-1 skin sensor temperature monitors and their associated probes because they have not been reviewed for safety and effectiveness for their intended use. The affected units were distributed from January 19, 2024, through January 19, 2026, across the US and in several other countries. The notice reports 692 affected units and no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact Physitemp Instruments or your care team before changing how you use this device.
  2. Check the model number (SST-1) and whether your unit was distributed between January 19, 2024, and January 19, 2026.
  3. The notice doesn't say how to get a repair, replacement or refund; contact Physitemp Instruments.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp SST-1 SKIN SENSOR Model/Catalog Number: SST-1 Software Version: N/A
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 10 products — see all of them.

Details

Units affected
692 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0401-2027

In the FDA's words

Description
Physitemp SST-1 SKIN SENSOR Model/Catalog Number: SST-1 Software Version: N/A 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: 692 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.

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