Kiwi Vacuum Assisted Delivery System Recall - Breakage Hazard

Health Canada has initiated a Type II recall for the Kiwi® Vacuum Assisted Delivery System (model VAC-6000MT) manufactured by Clinical Innovations, LLC of Murray, Utah. The recall addresses a potential breakage hazard at the Traction Force Indicator joint that may occur when traction is applied at approximately a 45-degree angle during delivery procedures. Health Canada classifies this as a Type II recall, indicating potential temporary or reversible health consequences. The original recall was published on 2026-04-01 with identification number RA-81826.

Healthcare providers and facilities should immediately identify whether they possess any units of the affected Kiwi® Vacuum Assisted Delivery System. All use of the affected product should be discontinued pending further instructions. Facilities should await contact from Clinical Innovations regarding return procedures and ensure that staff involved in obstetric care are aware of this safety concern. While no specific compliance deadline is stated, immediate action to identify and segregate affected inventory is warranted given the device failure risk during critical obstetric procedures.