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.

26–50 of 124

  • HighFDA (Devices)·Z-1594-2017·2017-04-05

    Resource Optimization Recalls 15 Sterile Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 15 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
    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-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-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-1634-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 25 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
    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-1560-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
    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-1631-2017·2017-04-05

    Recall of Robotic Hysterectomy Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1546-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 210 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens 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-1642-2017·2017-04-05

    FDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 230 sterile C-section procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1550-201·2017-04-05

    Recall of VP Shunt Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 55 VP Shunt procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1585-2017·2017-04-05

    Recall of Spohn Arthroscopy Kits Due to Splitting Light Glove Component

    Resource Optimization & Innovation LLC is recalling 36 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1641-2017·2017-04-05

    Recall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 690 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1592-2017·2017-04-05

    Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 590 sterile extremity packs because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2017·2017-04-05

    Recall of Regard Sterile Major Basin Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 1,548 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
    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-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-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-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-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-1566-2017·2017-04-05

    Recall of Sterile Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 32 sterile custom procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1590-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation Llc is recalling 180 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1571-2017·2017-04-05

    Recall of Regard Total Hip Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 14 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states