Recall Register

Clinical Innovations, LLC: FDA recalls

FDA enforcement reports name Clinical Innovations, LLC as the recalling firm in 8 events. The events have 9 product records. The recalls started from 2014 to 2026.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Clinical Innovations, LLC
InitiatedProduct (first record)TypeClassRecordsStatus
9 Mar 2026Brand 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…DeviceClass II1Ongoing
19 Jul 2022Sweetums 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, citric acid (buffer). Cup is latex-free, DEHP-free, BPA-free. UPC 00814247020673. Store at room…FoodClass II1Terminated
19 Jul 2022Sweetums 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 buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL…FoodClass II2Terminated
13 Aug 2020Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025DeviceClass II1Terminated
6 Aug 2019Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.DeviceClass II1Terminated
30 May 2019Clearview 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* * *." Each device is accompanied by Instruction for Use which is similarly labeled.DeviceClass II1Terminated
5 Jan 2015The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.DeviceClass II1Terminated
30 Dec 2014Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EODeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Clinical Innovations, LLC: events for each product type
TypeEvents
Device6
Food2
Clinical Innovations, LLC: events in each class
ClassEvents
Class II8
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Clinical Innovations, LLC, by the year that the recall started. The largest year is 2019, with 2 events.

Official channels

Cite this page

Recall Register. Clinical Innovations, LLC: FDA recalls. https://recallregister.com/firm/clinical-innovations-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
UT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Clinical Innovations, LLC have?
Class II: 8 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Clinical Innovations, LLC have?
Device: 6 events. Food: 2 events.
What is the newest FDA recall of Clinical Innovations, LLC?
FDA event 98597, which the firm started on 9 Mar 2026. The first product in the record is: 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…
How many FDA recalls of Clinical Innovations, LLC have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.