Clinical Innovations, LLC recalls Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery Syste

Recalling company

Clinical Innovations, LLC

Product

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.

Reason

Due to complaints of device breakage at the traction force gauge to handle joint.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 9, 2026

Reported

May 6, 2026

Distribution

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.

Status

Ongoing

Quantity

49,175 devices

Lot / codes

Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681

Company location

Murray, UT

Recall type

Voluntary: Firm initiated

Recall number

Z-1945-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1945-2026 in the FDA Enforcement Report. Also see FDA recall press releases.