Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni… — Class II medical device recall Z-1945-2026
Ongoing recall by Clinical Innovations, LLC, reported 2026-05-06, distributed nationwide. Due to complaints of device breakage at the traction force gauge to handle joint.
| Recall number | Z-1945-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Innovations, LLC, Murray, UT, United States |
| Recall initiated | 2026-03-09 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, CZ, JP, SG |
| Quantity | 49,175 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00814247020642 |
| Lot numbers | 251327, 251328, 251330, 251333, 251370, 251388, 251545, 251546, 251582, 251583, 251680, 251681 |
| Model numbers | VAC-6000MT |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1945-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.