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.

26–50 of 228

  • HighFDA (Devices)·Z-1670-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach

    Resource Optimization & Innovation LLC is recalling 32 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1636-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 92 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1618-2017·2017-04-05

    Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1608-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 209 sterile custom procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1650-2017·2017-04-05

    Recall of Regard Sterile Vascular Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 372 sterile vascular procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1596-2017·2017-04-05

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

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

    Product
    Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1656-2017·2017-04-05

    Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 249 sterile robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1597-2017·2017-04-05

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

    Resource Optimization & Innovation LLC is recalling 45 sterile procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1661-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 450 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1630-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
    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-1633-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 71 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1667-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Splitting Glove Component

    Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
    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
  • 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-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-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
  • 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-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-1653-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1547-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 90 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1573-2017·2017-04-05

    Resource Optimization Recalls Sterile Total Knee Procedure Trays Due to Glove Defect

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

    Product
    Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
    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-1629-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states