Resource Optimization & Innovation, LLC

Nashville, TN, US

Resource Optimization & Innovation, LLC appears in FDA device records in Nashville, TN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 230 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 0
PMA records: 0
Recall records: 230
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Resource Optimization & Innovation, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

ROi Consolidated Service Center (CSC)enforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Resource Optimization & Innovation, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004513970	3004513970	Resource Optimization & Innovation, LLC	1100 Dr Martin L King Jr Blvd Ste 1100, Nashville, TN 37203 US	2026	CCX DSW DXQ FMK FMR FNY FQL FQM FRL FRZ and 28 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 230

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0950-2022	Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site	A kit component, the PDI Prevantics Swab, was recalled.	Class II	2022-02-28	Terminated
Z-2699-2020	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.	The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.	Class II	2020-06-17	Terminated
Z-2369-2020	Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.	There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.	Class II	2020-05-04	Terminated
Z-2368-2020	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.	There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.	Class II	2020-05-04	Terminated
Z-2221-2019	Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.	Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.	Class II	2019-03-21	Open, Classified
Z-2220-2019	Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.	Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.	Class II	2019-03-21	Open, Classified
Z-0169-2018	Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.	Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.	Class II	2017-09-25	Open, Classified
Z-1678-2017	Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1677-2017	Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1676-2017	Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1675-2017	Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1674-2017	Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1673-2017	Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1672-2017	Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1671-2017	Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1670-2017	Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1669-2017	Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1668-2017	Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1667-2017	Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1666-2017	Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1665-2017	Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1664-2017	Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1663-2017	Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1662-2017	Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated
Z-1661-2017	Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn	Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.	Class II	2017-01-09	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain