Kiwi Omni Vacuum Delivery System Recall: Breakage Risk at Traction Gauge

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Contact the company & request your remedy

Recalling firmClinical Innovations, LLC747 W 4170 S · Murray, UT 84123-1364

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model number VAC-6000MT on the Kiwi Omni Vacuum Delivery System.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The device has broken at the traction force gauge during childbirth assistance, which could cause complications.

What should I do if I have this device?

The recall does not specify a remedy, so contact Clinical Innovations for guidance.

Which lot codes are affected?

Lot codes 251327, 251333, 251328, 251330, 251370, 251388, 251545, 251546, 251582, 251583, 251680, and 251681 are affected.

Take action

Contact Kiwi

We’ve drafted a message you can send Kiwi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1945-2026 — Kiwi Kiwi

Hello,

I own a Kiwi that is covered by recall Z-1945-2026 from Kiwi.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Clinical Innovations, LLC recalls Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number:

Lower-risk recall