Ohio recalls

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

Subpotent Drug

Presence of Foreign Substance

Failed PH Specifications

The recalled baby gyms violate the mandatory safety standard for infant support cushions because the floor mats can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.

The recalled spray bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, posing a risk of serious injury or death due to entrapment.

The recalled magnetic stick figure toy sets violate the mandatory standard for toys because the sets contain loose magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they 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.

The magnet ball toys violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they 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.

The recalled lighters violate the mandatory standard for multipurpose lighters because they do not have the required child-resistant mechanisms, posing a risk of serious injury or death from fire and burn hazards.

The recalled toys violate the mandatory standard for toys because they contain high-powered magnets which can loosen and 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.

The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller than permitted. The silicone strings can reach the back of the throat and become lodged, posing a risk of respiratory distress, serious choking hazard and death.

The power cord can become loose from the treadmill's power socket, posing a fire hazard.

The recalled chairs' legs can break, posing injury and fall hazards to consumers.

The recalled products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems, external medical devices, or underlying lung conditions who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by bacteria.

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Potential for microbial contamination.

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

Fungal contamination of affected lot with Parengyodontium album.

Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.