Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
25,676 detailed records are currently available in this category.
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.
Incomplete seals on the sterile package may compromise the sterility
Incomplete seals on the sterile package may compromise the sterility
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.
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…
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. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate,…
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
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.
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 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 gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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
Incomplete seals on the sterile package may compromise the sterility
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
