Class II — Clinical Innovations, LLC
| Recalling firm | Clinical Innovations, LLC |
|---|---|
| Registered facility | CLINICAL INNOVATIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 280 devices |
| Distribution | International distribution to the country Japan. |
| Initiated | 2019-05-30 |
| Classified | 2020-05-26 |
| Terminated | 2020-08-24 |
| Recall number | Z-2118-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Clinical Innovations, LLC (Z-2118-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85144/
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