Complete FDA and NHTSA recall records dated in September 2022.
These records include useful source details for the selected month.
Kia America, Inc. (Kia) is recalling certain 2016-2022 Sorento, 2021-2022 Sorento Hybrid (HEV), 2022-2023 Sorento Plug-In Hybrid (PHEV), and 2017-2022 Sportage vehicles equipped with a tow…
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside.…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Certain lots containing undersized dilator.
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the…
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of…
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the…
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of…
Possible undeclared Walnuts. Undeclared Yellow #5, Yellow #6 and Red #40.
Undeclared Soy, Yellow #5, Yellow #6, Blue #1, Red #3, and Red #40
Undeclared Soy, Yellow #5, Yellow #6, Red #40
Possible undeclared Walnuts. Undeclared Red #40.
Undeclared Soy, Yellow #5, Yellow #6 and Red #40
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.
