ClearView Uterine Manipulator, Long tip version with… recallZ-1817-2008 · Clinical Innovations, LLC · initiated May 12, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Clinical Innovations, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inadequate package seal could compromise sterility.
FDA root cause category: Process control
What the company is doing
Consignees were notified by letter on 05/12/2008 with instructions to conduct the recall to the end user. All remaining product is to be quarantined and returned to CI. A response form was included and a letter template to use in any sub-recall. Contact Richard Dixon at 801-268-8200 if you have questions.
Recall details
- Recall number
- Z-1817-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 12, 2008
- Posted by the FDA
- Sep 2, 2008
- Recalling firm
- Clinical Innovations, LLC
- Quantity
- 260 units
- Product code
- LKF
- FDA submissions
- K940681
- Distribution
- CA, CO, FL, MO, OR, VA. Foreign distribution to Mexico and United Kingdom. No military or government distribution.
Product description
ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Code information (models, lots, serial numbers)
Lot Number 080154
Other devices under the same FDA submission
2 devices cleared under K940681 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ClearView Uterine Manipulator UM700Clinical Innovations, LLC · Cannula, Manipulator/Injector, Uterine5 reports
- ClearView Uterine Manipulator UM900Clinical Innovations, LLC · Cannula, Manipulator/Injector, Uterine2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 48115).
- Z-1818-2008 · TerminatedClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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