Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60

FDA device recall Z-1945-2026 · posted 2026-04-24 · Open, Classified

Recall details

Recalling firm

Clinical Innovations, LLC

Reason for recall

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

Action taken

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 recalls@Laborie.com. 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HDB

Quantity affected

49,175 devices

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,

Date initiated

2026-03-09

Date posted

2026-04-24

Location

Murray, UT

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