The Recall Desk

Manufacturer

Resource Optimization & Innovation Llc

228 recalls in our database name Resource Optimization & Innovation Llc as the manufacturing or recalling firm.

What the numbers show

Total
228
Critical
0
Severe
19
Most recent
2022-04-27

Of the 228 recalls from Resource Optimization & Innovation Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 228

  • HighFDA (Devices)·Z-0950-2022·2022-04-27

    FDA recalls Regard IV Start Kit component over safety issue

    Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees in Missouri.

    Product
    Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2699-2020·2020-08-05

    Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction

    Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS GIC Port A Cath Due to Packaging Holes

    Resource Optimization & Innovation LLC is recalling Regard SRHS GIC Port A Cath devices because holes in the packaging may compromise the sterile field.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2020·2020-06-24

    Resource Optimization Recalls Regard SRHS Central Line Kits Due to Packaging Defects

    Resource Optimization & Innovation LLC is recalling Regard SRHS Central Line Kits because holes in the packaging may compromise the sterile field.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0169-2018·2017-11-29

    Resource Optimization Recalls Regard Custom Surgical Packs Due to Label Error

    Resource Optimization & Innovation LLC is recalling 51 units of Regard Custom Surgical Packs because they contain a 3ml ChloraPrep With Tint unit with an incorrect label.

    Product
    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1580-2017·2017-04-05

    Recall of Regard Open Heart Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 117 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1613-2017·2017-04-05

    FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1646-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 274 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1575-2017·2017-04-05

    FDA Recalls 170 Sterile Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 170 sterile laparoscopic procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1561-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 42 sterile custom procedure trays because a light glove component can split, potentially breaking the sterile field.

    Product
    Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1668-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 24 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1549-2017·2017-04-05

    Recall of Regard Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 208 Regard Total Joint Procedure Kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1551-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 112 sterile Spohn Shoulder System kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1622-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 148 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1671-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 454 Regard custom procedure trays because the included light gloves can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1545-2017·2017-04-05

    Recall of Regard sterile procedure trays due to glove splitting risk

    Resource Optimization & Innovation LLC is recalling 46 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1593-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 54 kits of Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1655-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 288 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1663-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 110 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1654-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 208 Spohn Shoulder System kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1643-2017·2017-04-05

    Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1581-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 96 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1595-2017·2017-04-05

    Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 12 kits of Regard sterile procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1619-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 356 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1559-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 156 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states