Clinical Innovations, LLC recalls Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60

Recalled May 6, 2026 · FDA recall Z-1945-2026 · Clinical Innovations

Hazard

Due to complaints of device breakage at the traction force gauge to handle joint. · FDA Class II

Units

49,175 devices

Sold at

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.

Description

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

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.

Manufacturer(s)

Clinical Innovations, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →