FDAMay 30, 2019device

Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.

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

The hazard

An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.

What to do

FDA enforcement status: Terminated

Brands named

clinical innovationsclinical

Recall history

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

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