# FDA recall Z-1945-2026

> **Clinical Innovations, LLC** · Class II · device recall initiated 2026-03-09.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-1945-2026
- **Recalling firm:** Clinical Innovations, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-09
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murray, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2026

## Citation

> AI Analytics. FDA recall Z-1945-2026. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1945-2026. Source: US FDA. Licensed CC0.

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