Resource Optimization & Innovation, LLC

United Statesfrom the FDA registration address FDA establishment FEI 3004513970

Devices: 0
Registrations: FDA
FDA recalls: 2280 ongoing since 2021 (1 open in total); 1 open since before 2021

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3004513970
Address: 1100 Dr Martin L King Jr Blvd Ste 1100, Nashville, TN, 37203

FDA recalls228

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 136
2018 0
2019 0
2020 3
2021 0
2022 1
2023 0
2024 0
2025 0
2026 0

88 initiated before 2017

Showing the 10 most recent of 228 recalls.

2022
- 28 Feb 2022 Z-0950-2022 Class II Terminated A kit component, the PDI Prevantics Swab, was recalled. Distribution: US distribution to two consignees located in Missouri
2020
- 17 Jun 2020 Z-2699-2020 Class II Terminated 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. Distribution: US Nationwide distribution including in the states of MO, NC, AR, OK. Submission number: K982188
- 4 May 2020 Z-2368-2020 Class II Terminated There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. Distribution: US Nationwide distribution including in the states of MO, NC.
- 4 May 2020 Z-2369-2020 Class II Terminated There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. Distribution: US Nationwide distribution including in the states of MO, NC.
2017
- 25 Sep 2017 Z-0169-2018 Class II Open since 2017 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. Distribution: Distributed domestically to Texas.
- 9 Jan 2017 Z-1544-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1545-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1546-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1547-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1548-201 Class II Terminated 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. Distribution: US Distribution to LA and TX.

Show the 25 most recent of 228 recalls

2017
- 9 Jan 2017 Z-1549-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1550-201 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1551-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1552-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1553-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1554-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1555-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1556-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1557-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1558-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1559-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1560-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1561-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1562-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.
- 9 Jan 2017 Z-1563-2017 Class II Terminated 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. Distribution: US Distribution to LA and TX.

This is an FDA establishment record without devices in deviCERTS.