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Kiwi OmniCup recallZ-1945-2026 · Clinical Innovations, LLC · initiated Mar 9, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Clinical Innovations, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to complaints of device breakage at the traction force gauge to handle joint.

FDA root cause category: Under Investigation by firm

What the company is doing

On 03/10/2026, the firm emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential of failure on the handle breaking at the Traction Force Indicator handle joint on the Kiwi Complete Vacuum Delivery System (VAC-6000MT) when angular force is applied to the handle. Customers are instructed to: 1. Identify and quarantine all unused inventory of the affected product. 2. Discontinue distribution of the affected product. 3. Return all unused, affected product to Clinical Innovations (Laborie), regardless of the labeled expiration date. 4. Complete and return the attached Recall Acknowledgement and Receipt Form within 15 business days, even if no inventory remains. Return the forms via email to [email protected]. 5. If customers have product to return, a company representative will contact them once Clinical Innovations has receive their Recall Acknowledgement and Receipt Form to issue them an RMA per company policy and arrange for a product return. For questions, call Clinical Innovations (Laborie), at 1-(888)- 268-6222 M-F 8:00 AM- 5:00 PM MT or + (33) 383 22 20 76 M-F 8:00 AM - 5 PM GMT +2 or their Clinical Innovation's (Laborie) service representative.

Recall details

Recall number
Z-1945-2026
Status
Open, Classified
Initiated by the company
Mar 9, 2026
Posted by the FDA
Apr 24, 2026
Recalling firm
Clinical Innovations, LLC
Quantity
49,175 devices
Product code
HDB
FDA submissions
K981260
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.

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.

Code information (models, lots, serial numbers)

Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K981260 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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