Kentucky recalls

Potential for incomplete scan due to unstable connection inside of floating sensor.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

Devices are not suitable for organ transplant.

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

Floating black foreign substance in the product

pathogen Cyclospora cayetanensis

Potential presence of Listeria monocytogenes.

Potential presence of Listeria monocytogenes.

May contain partially hydrogenated oils

May contain partially hydrogenated oils

Clear hard plastic fragments.

Clear hard plastic fragments.

Potential contamination with Salmonella.

Out of specification for dissolution.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Presence of particulate matter - Glass like particles.

Presence of particulate matter - Glass like particles.

Presence of particulate matter - Glass like particles.

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

The pedal axle can crack, causing the pedal to detach from the crank, posing a fall hazard to the rider.

The chargers can explode while in use, posing a fire and burn hazard.

The recalled toy kits violate the mandatory standard for toys containing button cell batteries because the compartment that holds the batteries can be easily accessed and opened by children, posing a deadly ingestion hazard to children. When button cell and coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

If the chandelier is hung at an angle on a vaulted ceiling or a sloped beam, the chandelier's canopy hardware can break, causing the chandelier to detach and fall from the ceiling, posing an impact hazard.

The recalled pounding toys violate the mandatory standard for toys because they contain high-powered magnets, which can detach, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, blood poisoning, and death.