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
- Set aside any SST-2 skin sensors from the affected lot codes distributed between January 19, 2024 and January 19, 2026.
- Contact Physitemp Instruments, LLC about the affected units.
- 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.
- Physitemp RET-1 Rectal Probe
Model/Catalog Number: RET-1Z-0399-2027 · 1165 units
- Physitemp ESO-1 FOR ESOPHAGEAL AND GENERAL PURPOSE USE
REF: ESO-1
.Z-0400-2027 · 169 units
- Physitemp SST-1 SKIN SENSOR
Model/Catalog Number: SST-1
Software Version: N/AZ-0401-2027 · 692 units
- Physitemp SST-2 SKIN SENSOR
REF: SST-2 (this page)Z-0402-2027 · 38 units
- Physitemp OT-1 ORAL THERMOCOUPLE PROBE
REF: OT-1Z-0403-2027 · 24 units
- Physitemp MT-D
REF: MT-DZ-0404-2027 · 36 units
- Physitemp TH-5 Thermalert Monitoring Thermometer
REF: TH-5Z-0405-2027 · 186 units
- Physitemp TH-5/AOP Thermalert Monitoring Thermometer with Analog Output
REF: TH-5/AOPZ-0406-2027 · 68 units
- Physitemp TH-8 Thermalert Monitoring Thermometer
REF: TH-8Z-0407-2027 · 36 units
- Physitemp TH-8/AOP Thermalert Monitoring Thermometer with Analog Output
REF: TH-8/AOPZ-0408-2027 · 16 units