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-1570-2017·2017-04-05

    FDA Recalls 18 Sterile Total Hip Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1639-2017·2017-04-05

    Recall of Regard Sterile Lap PK Spohn Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 3,000 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1659-2017·2017-04-05

    Recall of Regard Sterile Vaginal Kits Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 148 sterile vaginal kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1556-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation Llc is recalling 46 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1669-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

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

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    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-1574-2017·2017-04-05

    Recall of Regard Sterile Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 704 sterile laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1591-2017·2017-04-05

    Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 456 sterile extremity packs because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1612-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 158 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1640-2017·2017-04-05

    Recall of Regard Sterile Ortho PK Spohn Procedure Trays

    Resource Optimization & Innovation LLC is recalling 840 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
    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-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-1648-2017·2017-04-05

    Recall of Regard Sterile Neuro PK Spohn Procedure Trays

    Resource Optimization & Innovation Llc is recalling 1,056 sterile procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1676-2017·2017-04-05

    Recall of Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 30 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1645-2017·2017-04-05

    Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 1,224 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1587-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 10 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1564-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1569-2017·2017-04-05

    Resource Optimization Recalls 18 Sterile Total Hip Procedure Trays

    Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1666-2017·2017-04-05

    Recall of Spohn AV Access Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 118 Spohn AV Access Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1584-2017·2017-04-05

    Recall of Regard Major Vaginal PK Sterile Procedure Trays

    Resource Optimization & Innovation LLC is recalling 28 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1576-2017·2017-04-05

    Recall of Sterile Laparotomy Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 248 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1572-2017·2017-04-05

    Recall of Regard Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 22 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
    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-1632-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 46 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1617-2017·2017-04-05

    Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 42 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states