The equipment is designated a Class I recall, which is used for devices that may cause serious injuries or death, the agency said. They were distributed without FDA authorization.
The containers are sold under the brand names “HXBL,” “WETEX,” and “Genesis Biomedical,” the FDA said. They were distributed from Oct. 8 to Feb. 15.
The company is requesting that customers and distributors identify and destroy any of the unused equipment, the FDA said.
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