New York recalls

Clostridium botulinum (uneviscerated fish)

Defective container - seal not adhering to bottles

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Cross Contamination with Other Products

Incorrect Product Formulation

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Failed stability specifications: Out of specification for hardness test

Failed stability specifications: Out of specification for hardness test

Misbranding, Unreported Allergens

The recalled youth ATVs violate the mandatory ATV safety standard. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. Additionally, the handlebars pose a laceration hazard, if the child rider's body or head impacts the handlebars at high speed. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.

The ice crusher can experience a thermal event and ignite, posing a fire hazard.

The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or death due to drowning.

The steamers can leak or spit hot water, posing a risk of serious burn injury to users and bystanders. The water tank cap can also leak or detach during use, exposing users to hot water.

The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant walkers have leg openings that allow the child to slip down until the child's head can become entrapped, posing a risk of serious injury or death.

The children's costumes contain a prohibited phthalate, which violates the federal phthalates ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.

The wooden button on the soother clips can come off, exposing a sharp screw, which can pose choking and laceration hazards.

The bolts on the chainring can come loose, causing the chainring to separate from the bike, resulting in a fall or crash hazard to the user.

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.