RegWardenFDA facility compliance records
Company

Resource Optimization & Innovation

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 4 recalls; 2017: 2 recalls; 2020: 2 recalls; 2022: 1 recalls4201520162201720182019220202021120222023202420252026
  • Recalls (9)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2022-02-28
    A kit component, the PDI Prevantics Swab, was recalled.
  • Class IITerminated2020-06-17
    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 IITerminated2020-05-04
    There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
  • Class IIOngoing2017-09-25
    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 incorrec…
  • Class IITerminated2017-01-09
    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 IITerminated2015-08-25
    The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
  • Class IITerminated2015-08-25
    Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
  • Class IITerminated2015-08-19
    Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
  • Class IITerminated2015-04-22
    The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Resource Optimization & Innovation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10026387-resource-optimization-innovation/

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