Recall Register

Resource Optimization & Innovation LLC: FDA recalls

FDA enforcement events from 2015 to 2022; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Resource Optimization & Innovation LLC as the recalling firm in 9 events. The events have 228 product records. The recalls started from 2015 to 2022. All the events are device recalls. By FDA enforcement events, Resource Optimization & Innovation LLC is number 386 of 1,628 firms that have a page. Events that Resource Optimization & Innovation LLC started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

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

9 events, newest first.

FDA enforcement events of Resource Optimization & Innovation LLC
InitiatedProduct (first record)TypeClassRecordsStatus
28 Feb 2022Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access siteDeviceClass II1Terminated
17 Jun 2020regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.DeviceClass II1Terminated
4 May 2020Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.DeviceClass II2Terminated
25 Sep 2017Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.DeviceClass II1Ongoing
9 Jan 2017Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus HighlandDeviceClass II135Terminated
25 Aug 2015Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.DeviceClass II8Terminated
25 Aug 2015Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.DeviceClass II1Terminated
19 Aug 2015Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.DeviceClass II2Terminated
22 Apr 2015regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedureDeviceClass II77Terminated

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

Resource Optimization & Innovation LLC: events for each product type
TypeEvents
Device9
Resource Optimization & Innovation LLC: events in each class
ClassEvents
Class II9
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 Resource Optimization & Innovation LLC, by the year that the recall started. The largest year is 2015, with 4 events.

Official channels

Cite this page

Recall Register. Resource Optimization & Innovation LLC: FDA recalls. https://recallregister.com/firm/resource-optimization-innovation-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
MO

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 rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Resource Optimization & Innovation LLC have?
Class II: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Resource Optimization & Innovation LLC?
FDA event 89793, which the firm started on 28 Feb 2022. The first product in the record is: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
How many FDA recalls of Resource Optimization & Innovation 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.