South Carolina recalls

Firm is initiating a removal due to continued reports of adverse events.

Firm is initiating a removal due to continued reports of adverse events.

A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

Due to damage to outer tray that can potentially compromise the sterile barrier

Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Potential packaging failures, which could lead to a breach in the sterile barrier.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

Issue with software algorithm which may lead to overpressure events.

Potential to be contaminated with Salmonella

The recalled magnetic chess games violate the mandatory standard for toys because they contain loose magnets 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.

Product Contamination

The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.

The recalled book nooks violate the mandatory standard for consumer products containing button cell or coin batteries because the nooks include a spare lithium coin battery that can be easily accessed by children. In addition, the spare coin battery is not in child resistant packaging, and the packaging does not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings required by Reese's Law. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled vinegar product violates the precautionary labeling requirements under the Federal Hazardous Substances Act (FHSA) because the hazardous substance lacks required warning labels and first-aid treatment instructions. This poses a deadly risk of poisoning if the contents are swallowed and a serious injury from chemical burns to the skin and eyes if improperly handled.

The recalled magnet toy building sets violate the mandatory standard for toys because they contain small balls and are intended for children under three years of age, posing a deadly choking hazard.

The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

Product Contamination

This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.