Moderate riskFDA DeviceClass II

Physitemp SST-2 skin sensor recalled, not reviewed for safety

Physitemp temperature monitors and associated probes, model SST-2, have not been reviewed for safety and effectiveness for their intended use. The affected lot codes were distributed between January 19, 2024 and January 19, 2026, and the notice lists 38 units. The notice reports no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside any SST-2 skin sensors from the affected lot codes distributed between January 19, 2024 and January 19, 2026.
  2. Contact Physitemp Instruments, LLC about the affected units.
  3. The notice doesn't say how to get a replacement or refund; ask Physitemp Instruments, LLC.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp SST-2 SKIN SENSOR REF: SST-2
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 10 products — see all of them.

Details

Units affected
38 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0402-2027

In the FDA's words

Description
Physitemp SST-2 SKIN SENSOR REF: SST-2 Temperature monitors and associated probes have not been reviewed for safety and effectiveness for intended use. All lot codes distributed between January 19, 2024 through January 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: 38 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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