All Recalls

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 (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

Incomplete seals on the sterile package may compromise the sterility

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 (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Incomplete seals on the sterile package may compromise the sterility

Incomplete seals on the sterile package may compromise the sterility

Potential for leakage at the joint between the blood filters and tubing

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

Firm has received reports of leading end catheter component separations.

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

The lot contained two outer pins instead of one outer and one inner pin.

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

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 (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

Incomplete seals on the sterile package may compromise the sterility