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Primo Passi

Primo Passi LLC · Model JPD-FR300 · UDI-DI 00850000125469

FLL

510(k) clearances

1,636

Adverse events (13 deaths)

Recalls

474

Facilities

Description

Primo Passi Ear and Forehead Thermometer, Model SK-158 (JPD-FR300). Electrically powered, non-contact infrared thermometer intended for the measurement of human body temperature via the ear canal or forehead. Automatically switches between ear mode and forehead mode based on probe cover position. Features passive infrared receiving technology with advanced infrared temperature sensor. Provides measurement results in approximately 1 second with a single button operation. Includes fever alert function and automatic temperature calibration. Displays temperature in Celsius or Fahrenheit. Forehead mode applicable to all age groups. Ear mode applicable to children older than 3 months, adults, and elderly. Child mode available for users under 12 years of age. Automatic power-off function. Powered by 2 AAA batteries. BPA-free materials. Single-use patient, multiple-use device.

Recalls

Date	Firm	Reason
2026-08-20	DeRoyal Industries Inc	Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
2025-09-17	Baxter Healthcare Corporation	Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, w
2024-06-13	Baxter Healthcare Corporation	The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
2021-07-20	Welch Allyn Inc	If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the us
2019-10-28	Cardinal Health 200, LLC	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28	Cardinal Health 200, LLC	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28	Cardinal Health 200, LLC	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28	Cardinal Health 200, LLC	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28	Cardinal Health 200, LLC	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2018-02-02	Philips Consumer Lifestyle	Device may provide inaccurate measurements.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.