Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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
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.
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…
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 lot contained two outer pins instead of one outer and one inner pin.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Firm has received reports of leading end catheter component separations.
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.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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 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…
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
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…
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.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
