Kiwi Omni Vacuum Delivery System Recall: Breakage Risk at Traction Gauge
Clinical Innovations recalls Kiwi Omni Vacuum Delivery System (VAC-6000MT) due to reported breakage at the traction force gauge during childbirth assistance. Affected units sold in specific lots.
Lower-risk recall
Due to complaints of device breakage at the traction force gauge to handle joint.
Contact the company
What happened, in plain English
Clinical Innovations recalls the Kiwi Omni Vacuum Delivery System (model VAC-6000MT) because it has broken at the traction force gauge during childbirth assistance. This could lead to complications if the device fails while being used. Read more at govinfonow.com/recall/49771-kiwi-omni-vacuum-delivery-system-recall-breakage-risk-at-traction.
Source Summary by GovInfoNow · govinfonow.com/recall/49771-kiwi-omni-vacuum-delivery-system-recall-breakage-risk-at-traction · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1945-2026
Cite this page
“Kiwi Omni Vacuum Delivery System Recall: Breakage Risk at Traction Gauge.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49771-kiwi-omni-vacuum-delivery-system-recall-breakage-risk-at-traction. Based on FDA recall #Z-1945-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1945-2026%22&limit=1).
Why it’s dangerous
The device's traction force gauge can break during childbirth assistance, potentially causing complications if the device fails while being used. This breakage occurs under conditions like term pregnancy, ruptured amniotic membranes, or engaged head.
Who’s affected
Healthcare providers using the Kiwi Omni Vacuum Delivery System for childbirth assistance. Pregnant individuals with specific medical conditions may be at risk if the device breaks during delivery.
How to tell if you have this one
Check for model number VAC-6000MT on the device. Affected units were sold with lot codes 251327, 251333, 251328, 251330, 251370, 251388, 251545, 251546, 251582, 251583, 251680, and 251681.
- Brand
Kiwi- Category
Medical device
What to do — step by step
Check Device Model
Look for model number VAC-6000MT on the Kiwi Omni Vacuum Delivery System.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New York, North Carolina, Ohio, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1945-2026 (March 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1945-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.