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Moderate riskFDA DeviceClass II

Physitemp TH-5/AOP thermometers recalled for unreviewed safety

Physitemp Instruments recalled 68 TH-5/AOP Thermalert monitoring thermometers and their associated probes. The FDA notice says these devices have not been reviewed for safety and effectiveness for their intended use. No injuries are reported. The affected units were distributed between January 19, 2024, and January 19, 2026, in several US states and other countries.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact your care team or Physitemp Instruments before stopping use of the device, since it monitors temperature.
  2. Check whether your TH-5/AOP thermometer 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 or where you bought it.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp TH-5/AOP Thermalert Monitoring Thermometer with Analog Output REF: TH-5/AOP
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 10 products — see all of them.

Details

Units affected
68 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0406-2027

In the FDA's words

Description
Physitemp TH-5/AOP Thermalert Monitoring Thermometer with Analog Output REF: TH-5/AOP 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: 68 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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