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.
USBrand 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.
Recalling Firm: Clinical Innovations, LLC
Reason for Recall / Hazard
Due to complaints of device breakage at the traction force gauge to handle joint.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Murray |
| State | UT |
| Event id | 98597 |
| Address 1 | 747 W 4170 S |
| Code info | Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681 |
| Postal code | 84123-1364 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 49,175 devices |
| Reason for recall | Due to complaints of device breakage at the traction force gauge to handle joint. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260309 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmClinical Innovations, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Clinical Innovations, LLC - 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. Check if your household is affected: https://therecallfile.com/recalls/brand-name-kiwi-omni-vacuum-delivery-system-product-name-kiwi-omni-vac/FDA-Z-1945-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKCobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
Cobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery (DSI/2026/010)
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of rev...
UKNGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
NGPod pH testing device: quarantine and dispose of all devices (DSI/2026/009)
The NGPod handheld device and NGPod sensor, used to test pH to aid the placement of nasogastric tubes, is being withdrawn from the UK market. The manufacturer has ceased trading in the UK. Users shoul...
UKField Safety Notices: 17 to 21 August 2026
Field Safety Notices: 17 to 21 August 2026
List of Field Safety Notices from 17 to 21 August 2026....