Complete FDA and NHTSA recall records dated in December 2018.
These records include useful source details for the selected month.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
cGMP violations noted during the firm's most recent inspection.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
BMW of North America, LLC (BMW) is recalling certain 2019 BMW X5 xDrive40i and X5 xDrive50i vehicles. The driver and/or passenger sun visor may have an incorrect air bag warning label, or…
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2018-2019 Volkswagen Atlas, 2015 Volkswagen Golf SportWagen, and 2019 Volkswagen Jetta vehicles. The rear coil springs…
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2019 Toyota Corolla hatchback vehicles equipped with Continuously Variable Transmissions (CVT). The pump impeller…
Ford Motor Company (Ford) is recalling certain 2015-2019 Ford F-150 and 2017-2019 Ford F-250 Super Duty, F-350 Super Duty, F-450 Super Duty, and F-550 Super Duty pick-up trucks equipped…
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2018-2019 Toyota Tacoma vehicles. Improper machining of the brake master cylinder may result in internal damage of one…
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its…
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
The firm received complaints of the wrap coming apart and leaking granular material
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the…
The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD…
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
