# FDA recall Z-2118-2020

> **Clinical Innovations, LLC** · Class II · device recall initiated 2019-05-30.

## Product

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.

## Reason for recall

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.

## Distribution

International distribution to the country Japan.

## Key facts

- **Recall number:** Z-2118-2020
- **Recalling firm:** Clinical Innovations, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-30
- **Report date:** 2020-06-03
- **Termination date:** 2020-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murray, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2118-2020

## Citation

> AI Analytics. FDA recall Z-2118-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2118-2020. Source: US FDA. Licensed CC0.

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