Recall Z-1945-2026 ยท HDB Extractor, Vacuum, Fetal
Clinical Innovations, LLC
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 membrane
| Date | Apr 24, 2026 (initiated Mar 9, 2026) |
| Status | Open, Classified |
| Reason | Due to complaints of device breakage at the traction force gauge to handle joint. |
| 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 ret |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc., Sep 22, 1998 |