Recall Weekly
Moderate riskFDA DeviceClass II

Physitemp RET-1 rectal probe recalled, not reviewed for safety

Physitemp Instruments, LLC is recalling the RET-1 rectal probe because temperature monitors and associated probes have not been reviewed for safety and effectiveness for their intended use. No injuries have been reported. The recall covers lots distributed from January 19, 2024 through January 19, 2026, with 1,165 units affected.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside RET-1 probes from lots distributed between January 19, 2024 and January 19, 2026, and talk to your care team before using them.
  2. Check the lot code on each RET-1 probe to see whether it falls within that date range.
  3. Contact Physitemp Instruments, LLC about affected units; the notice does not say how to get a remedy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Physitemp RET-1 Rectal Probe Model/Catalog Number: RET-1
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 10 products — see all of them.

Details

Units affected
1165 units
Illnesses reported
None reported
Manufactured in
189 Sargeant Ave, Clifton, New Jersey, United States
Classification
Class II
Recall number
Z-0399-2027

In the FDA's words

Description
Physitemp RET-1 Rectal Probe Model/Catalog Number: RET-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: 1165 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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