All Recalls

The lithium-ion batteries in the HALO 1000 Portable Power Station can overheat, posing fire and burn hazards that can lead to serious injury or death.

Due to elevated levels of lead. Sample collected by Maryland Department Of Health (MDDH) tested positive for high levels of lead in ground cinnamon.

Product contains elevated levels of lead (2,030 ppb)

Foreign material (metal)

Product contains inorganic arsenic above action level set in industry guidance (13.2ppb)

Undeclared Soy. Carrot Cake slices were inadvertently placed into some Chocolate Cake slice containers. The Chocolate Cake ingredient statement does not list the allergen soy which is in the Carrot Cake.

undeclared milk

Superpotent Drug

CGMP Deviations: sterile water not used for production

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

CGMP Deviations: sterile water not used for production

Lack of Assurance of Sterility

Presence of Particulate Matter

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

At least two units have been found to be missing a weld.

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.