Z-1945-2026Class II

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog...

Name: Z-1945-2026 Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog...
Creator: Clinical Innovations, LLC
Published: 2026-03-09
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2026-03-09 / Open, Classified

FDA source

Clinical Innovations, LLC began a recall of Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical... on 2026-03-09. FDA classified it as Class II and gives the reason as "Due to complaints of device breakage at the traction force gauge to handle joint". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1945-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-09
Posted: 2026-04-24
Recalling firm: Clinical Innovations, LLC
Product: 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.
Product code: HDB Extractor, Vacuum, Fetal
Reason for recall: Due to complaints of device breakage at the traction force gauge to handle joint.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.
Product codes and lots: Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24

Product code HDB

K981260Class IIKiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000MClinical Innovations, Inc. / cleared 1998-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)