Recall Weekly
Moderate riskFDA DeviceClass II

Physitemp OT-1 oral thermocouple probe recalled for unreviewed safety

Physitemp Instruments recalled OT-1 oral thermocouple probes because temperature monitors and their probes have not been reviewed for safety and effectiveness for their intended use. The recall covers lot codes distributed from January 19, 2024 through January 19, 2026, and 24 units are affected. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Clinicians should set aside OT-1 probes from lot codes distributed between January 19, 2024 and January 19, 2026.
  2. Check the lot codes on your OT-1 probes against that date range.
  3. The notice doesn't say how to get a replacement or refund; contact Physitemp Instruments, LLC.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp OT-1 ORAL THERMOCOUPLE PROBE REF: OT-1
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 10 products — see all of them.

Details

Units affected
24 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0403-2027

In the FDA's words

Description
Physitemp OT-1 ORAL THERMOCOUPLE PROBE REF: OT-1 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: 24 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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