FDA recall, , Moderate risk
Kiwi Omni Vacuum Delivery System
Due to complaints of device breakage at the traction force gauge to handle joint.
Summary by Recall Canary from the FDA notice
What happened
Clinical Innovations, LLC, of Murray, Utah, is recalling the Kiwi Omni Vacuum Delivery System, model VAC-6000MT, due to complaints of device breakage at the traction force gauge to handle joint. The recall began March 9, 2026, and was added to the FDA's Enforcement Report on April 24, 2026. The device is a sterile, single-patient-use vacuum assisted fetal delivery system for childbirth under specific conditions.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Kiwi Omni Vacuum Delivery System
- Model number
- VAC-6000MT
- Lot code
- 251327
- 251333
- 251328
- 251330
- 251370
- 251388
- 251545
- 251546
- 251582
- 251583
- 251680
- 251681
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, PR, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. The countries of Canada, China, Japan, Czech Republic, and Singapore.
- Company
- Clinical Innovations, LLCMurray, Utah
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98597
- Recall number
- Z-1945-2026
- Quantity recalled
- 49,175 devices
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
