Ohio recalls

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Products may contain elevated levels of lead.

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Undeclared allergen - milk

Undeclared allergen - milk

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Subpotent drug; Clavulanate Potassium component

The recalled bed rails violate the mandatory standard for children's portable bed rails because, when installed adjacent to the bed, the child can become entrapped in the enclosed openings, the openings on the side of the mattress, and the openings on top of the mattress, posing a risk of serious injury or death due to entrapment.

The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire.

The pump's canister can forcefully eject from the base when pressurized, posing a risk of serious injury from impact to the user or bystander.

The recalled bed rails violate the mandatory standard for adult portable bed rails, posing a serious entrapment hazard and risk of death by asphyxiation. 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. In addition, the bed rails do not have the required warning labels.

The recalled toys are intended for children under three years of age and the eyes can detach, which violates the small parts ban, posing a choking hazard to children.

The swings were marketed for infant sleep and have an incline angle greater than 10 degrees, violating the mandatory safety standard for Infant Sleep Products and the ban on inclined sleepers under the Safe Sleep for Babies Act, posing a deadly suffocation risk.

The recalled nightgowns violate the mandatory flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The fan wheel inside the backpack blower can break apart, posing a laceration hazard.

The recalled infant bath tubs violate the mandatory standard for consumer products containing button cell or coin batteries because the built-in thermometer contains button cell batteries that can be accessed easily by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The left front wheel can detach during use, posing a fall hazard.