Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Clearview Total Uterine Manipulator (model UM750) Recalled by Clinical Innovations, LLC Due to An incorrect component used during manufacturing. The uterine...

Date: May 30, 2019
Company: Clinical Innovations, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Clinical Innovations, LLC directly.

Affected Products

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.

Quantity: 280 devices

Why Was This Recalled?

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.

Where Was This Sold?

International distribution to the country Japan.

About Clinical Innovations, LLC

Clinical Innovations, LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report