Resource Optimization & Innovation LLC

FDA recalling firm · 9 enforcement events · 228 product records · 2015–2022 · MO

Resource Optimization & Innovation LLC has 9 FDA enforcement events on this register (228 product records) between 2015 and 2022: 9 device; the busiest year was 2015 with 4.

0% of its events are Class I; the most common class is Class II (9). 1 event is listed as ongoing; the recalling firm's address is in MO.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
28 Feb 2022	Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site	Device	Class II	1	Terminated
17 Jun 2020	regard 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.	Device	Class II	1	Terminated
4 May 2020	Regard 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.	Device	Class II	2	Terminated
25 Sep 2017	Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.	Device	Class II	1	Ongoing
9 Jan 2017	Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland	Device	Class II	135	Terminated
25 Aug 2015	Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.	Device	Class II	8	Terminated
25 Aug 2015	Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.	Device	Class II	1	Terminated
19 Aug 2015	Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.	Device	Class II	2	Terminated
22 Apr 2015	regard 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 procedure	Device	Class II	77	Terminated

By type and class

Device9

Class II9

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Resource Optimization & Innovation LLC by year initiated.

Questions and answers

How many FDA recalls has Resource Optimization & Innovation LLC had?

9 enforcement events (228 product records) on this register, 2015–2022: 9 device.

Are any Resource Optimization & Innovation LLC recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Resource Optimization & Innovation LLC recalls?

9 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.