Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

Class II

Recalling firm: Clinical Innovations, LLC
Reason for recall: Due to complaints of device breakage at the traction force gauge to handle joint.
Affected products (lot / model / serial): Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681
Units affected: 49,175 devices
Distribution pattern: Worldwide - U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MI, MN, MS, NC, NE, NH, NV, NY, OH, PR, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.
Firm location: Murray, UT, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-1945-2026
Recall initiated: March 9, 2026
FDA classification date: April 24, 2026
FDA report date: May 6, 2026
FDA event ID: 98597
Last updated on HTM Vibe: July 24, 2026