Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
Shenzhen Shuanglong Home Furnishing Co., Ltd., of China
🏠 Consumer Products Class I - Dangerous
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers violate the mandatory standard required by the STURDY Act.
The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and the enclosed openings at the foot of the loungers are wider than allowed, posing fall and entrapment hazards to infants. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.
The recalled tables and desks can collapse when a gap forms between the leg and tabletop and a horizontal force is applied to the top, posing a risk of injury.
The recalled PTV can leak fuel at the quick-connect fitting between the fuel line and the fuel injector mounted on the engine, posing a risk of serious injury and fire hazard.
The exhaust duct can crack, allowing gases to escape inside of the home, posing a carbon monoxide (CO) poisoning hazard that can result in death or serious injury.
The ethanol fuel bottles violate the federal safety standard for portable fuel containers because they lack flame mitigation devices required by the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. The fuel containers also fail to meet the federal safety regulation for deceptive disclaimers required by the Federal Hazardous Substances Act because they claim the contents are "Non Toxic".
Jiangsu Pengcheng Weiye Furniture Co., Ltd., of China
🏠 Consumer Products Class I - Dangerous
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.