The Recall Desk

Hazard

Sterile Field Breach recalls

124 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
124
Critical
0
Severe
6
Most recent
2017-04-05

Of the 124 sterile field breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (5%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile field breach recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–124 of 124

  • 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-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
  • HighFDA (Devices)·Z-1601-2017·2017-04-05

    Recall of Regard Sterile Abdominal PK Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 290 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1552-2017·2017-04-05

    FDA Recalls Sterile Breast Procedure Kits Due to Glove Splitting Risk

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

    Product
    Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1582-2017·2017-04-05

    FDA Recalls 120 Sterile Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 120 sterile Total Joint Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1563-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
    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-1610-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

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

    Product
    Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
    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-1606-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
    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-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-1603-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 40 kits of Regard sterile custom 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-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-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