FDA Medical Device Recalls (openFDA)
Clinical Innovations, LLC: 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.
- Recall number
- Z-2118-2020
- Recalling firm
- Clinical Innovations, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-05-30
- Posted
- not on file
- Terminated
- 2020-08-24
- 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.
- Root cause
- Process control
- Action
- On July 2, 2019, the firm sent an field Safety Notice letter to consignees. In addition to informing consignees about the recall they asked that the following actions be taken: 1. Please provide the field safety notice to your hospitals. If you have further distributed this product, please identify your customers and notify them at once of this communication and/or contact Clinical Innovations with the contact information s that we can follow-up with the owner of the device. 2. Please quarantine any remaining product in your hospitals and completed the response card attached to this filed safety notice. A company representative will contact you and arrange for the return of the product. 3. If you have any questions, please call Clinical Innovations at 1-8880268-6222, M-F, 8:00 Am 5:00 PM MT
- Quantity
- 280 devices
- Distribution
- International distribution to the country Japan.
- Lot, serial or model codes
- Model Number: UM750 Lot Number: 181183
- 510(k) numbers
- ["K131781"]
- PMA numbers
- not on file
- Product code
- LKF
- Firm FEI
- 1000220650
- Firm city
- Murray
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28