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FDAOctober 19, 2016device

Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

What to do

FDA enforcement status: Terminated

Brands named

ultroid technologiesultroid

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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