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Geratherm Daisy Color Pacifier Digital Thermometer

R.G. ENTERPRISES (U.S.A.), INC. · Model RETAIL Baby Pacifier Thermometer · UDI-DI 00614801300704

FLL

510(k) clearances

1,321

Adverse events (13 deaths)

Recalls

479

Facilities

Description

Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement of oral body temperature in infants and young children. The device is waterproof, uses a CR2032 (3 V) battery. Dimensions: 60 mm x 50 mm x 42 mm. Weight: Approx. 23 grams (including battery). Beeper: Approx. 5 secs. sound signal when end temperature reached. Memory: Built-in memory enabling display of the previously measured value. Shut-off: Automatic shut-off in approx. 30 seconds. Backlight Color Coded Visual fever alarm indicators green yellow and red : 36,0 T 37,1 green 37,2 T 37,4 yellow 37,5 T 43,9 red A protective storage cover included

Recalls

Date	Firm	Reason
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Corporation	The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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.
2017-10-17	3M Company - Health Care Business	During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower

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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.