Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60
Summary
The FDA issued a Class II for Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Deli by Clinical Innovations, LLC. Reason: Due to complaints of device breakage at the traction force gauge to handle joint..
Details
Source
Device Recall
External ID
Z-1945-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681
Quantity Affected: 49,175 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-09
Company
Murray, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Clinical Innovations, LLC has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Clinical Innovations, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Clinical Innovations, LLC have FDA actions?
Clinical Innovations, LLC has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1945-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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