305 recalls tagged with “federal law violation”.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Hyundai Motor America (Hyundai) is recalling certain 2025-2026 Tucson and Santa Fe vehicles. The connecting rod bolts in the engine may have been improperly tightened, which can cause a loss of drive power and engine damage, possibly resulting in an oil leak.
Kia America, Inc. (Kia) is recalling certain 2025 K4 and Sorento vehicles. The connecting rod bolts in the engine may have been improperly tightened, which can cause a loss of drive power.
Presence of a foreign substance.
One lot manufactured with an invalid sterilization cycle.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.