Recall Weekly
Moderate riskFDA DeviceClass II

Physitemp ESO-1 temperature monitors recalled for unclear intended use

Physitemp Instruments recalled ESO-1 temperature monitors and associated probes because they have not been reviewed for safety and effectiveness for their intended use. The units were packaged and labeled without a clear intended use statement. The notice reports 169 affected units and no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside ESO-1 units distributed between January 19, 2024 and January 19, 2026 that were labeled without a clear intended use statement.
  2. Contact Physitemp Instruments about the affected units. The notice doesn't say what remedy is offered, so ask the manufacturer or where the units were purchased.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp ESO-1 FOR ESOPHAGEAL AND GENERAL PURPOSE USE REF: ESO-1 .
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 10 products — see all of them.

Details

Units affected
169 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0400-2027

In the FDA's words

Description
Physitemp ESO-1 FOR ESOPHAGEAL AND GENERAL PURPOSE USE REF: ESO-1 . 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, that were packaged and labeled without a clear intended use statement. This 24-month distribution scope reflects the consumable nature and operational lifespan of these component probes within laboratory environments. 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: 169 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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