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.

101–125 of 228

  • HighFDA (Devices)·Z-1586-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 48 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1625-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

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

    Product
    Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1660-2017·2017-04-05

    FDA Recalls Sterile Vaginal Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 56 sterile major vaginal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1678-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 660 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1554-2017·2017-04-05

    Recall of Regard Sterile C Section Packs Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 320 sterile C Section Packs because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1672-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 212 Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1609-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 55 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1579-2017·2017-04-05

    Recall of Regard Ortho PK Spohn Custom Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation Llc is recalling 460 Regard Ortho PK Spohn custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407002, Sterile, OR0476B - Ortho 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-1583-2017·2017-04-05

    Recall of Spohn Total Joint PK Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 86 sterile Total Joint PK procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
    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-1623-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 150 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1628-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 384 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
    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-1638-2017·2017-04-05

    Recall of Regard Sterile Laparoscopic Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 5,000 sterile laparoscopic procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1544-2017·2017-04-05

    Resource Optimization Recalls Sterile Robotic Laparoscopic Procedure Trays

    Resource Optimization & Innovation LLC is recalling 41 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1677-2017·2017-04-05

    Recall of Regard Sterile C Section Packs Due to Glove Splitting Risk

    Resource Optimization & Innovation Llc is recalling 670 sterile C Section Packs because a light glove component can split, potentially breaking the sterile field.

    Product
    Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1616-2017·2017-04-05

    Recall of Pediatric Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 430 sterile pediatric procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1614-2017·2017-04-05

    Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 70 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1589-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 344 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800524003, Sterile, LD0608C - C Section - 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-1627-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 165 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1602-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
    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-1647-2017·2017-04-05

    Recall of Regard Sterile Open Heart Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 228 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states