Murray, UT, United States
Clinical Innovations, LLC recalls
6 recalls recorded since 2018, most recently on 9 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 March 2026
- Reason
- Due to complaints of device breakage at the traction force gauge to handle joint.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1945-2026
- 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 deliv
Terminated Class II Food
- Recall started
- 19 July 2022
- Terminated
- 20 March 2023
- Reason
- Firm received complaints of leaking, black liquid, and black particulates in the product vials.
- Distribution
- Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-1685-2022, F-1684-2022
- Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or b
- Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or
Terminated Class II Food
- Recall started
- 19 July 2022
- Terminated
- 9 February 2023
- Reason
- Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-1682-2022
- Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptically packaged in 15 mL cups with foil lid. Each cup contains 15 mL of USP purified water, 24% sugar,
Terminated Class II Medical devices
- Recall started
- 13 August 2020
- Terminated
- 24 May 2024
- Reason
- Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
- Distribution
- US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0541-2021
- Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Terminated Class II Medical devices
- Recall started
- 6 August 2019
- Terminated
- 16 September 2022
- Reason
- There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
- Distribution
- OUS customers only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2072-2020
- Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Terminated Class II Medical devices
- Recall started
- 30 May 2019
- Terminated
- 24 August 2020
- Reason
- An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
- Distribution
- International distribution to the country Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2118-2020
- Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.