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Recall Canary
Kiwi Omni Vacuum Delivery System
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MEDICAL DEVICE RECALLMODERATE

Kiwi Omni Vacuum Delivery System

Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to a risk of device breakage during use.

What to do

Stop using the affected vacuum delivery system immediately and contact Clinical Innovations for further instructions regarding the return or disposal of the device.

Recalled
Listed
Updated
Recall No.
Z-1945-2026
Agency
FDA
Firm
Clinical Innovations, LLC
Recall ID
98597
Status
ONGOING

Recall at a glance

Quantity recalled
49,175 devices

Why it was recalled

Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System due to reports of device breakage at the joint between the traction force gauge and the handle. The affected model is VAC-6000MT.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Kiwi Omni Vacuum Delivery System

UDI-DI
00814247020642
Model/Catalog number
VAC-6000MT

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification