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.
Incomplete seals on the sterile package may compromise the sterility
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Incomplete seals on the sterile package may compromise the sterility
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 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…
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming…
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Incomplete seals on the sterile package may compromise the sterility
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming…
Incomplete seals on the sterile package may compromise the sterility
Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate,…
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were…
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.
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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.
