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.

51–75 of 124

  • 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-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-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-1568-2017·2017-04-05

    Recall of Pacemaker Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 26 sterile pacemaker procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1599-2017·2017-04-05

    FDA Recalls 460 Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 460 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1598-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 834 sterile lap chole kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1658-2017·2017-04-05

    Recall of Spohn Laparoscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 92 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1673-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

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

    Product
    Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
    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-1626-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559002, Sterile, ET0648B - 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-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-1644-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 2,016 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1578-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Procedure Trays Due to Glove Defect

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

    Product
    Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1600-2017·2017-04-05

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

    Resource Optimization & Innovation Llc is recalling 200 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
    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-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-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-1557-2017·2017-04-05

    Resource Optimization & Innovation Recalls Sterile Breast PK Procedure Trays

    Resource Optimization & Innovation Llc is recalling 16 sterile breast PK procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
    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-1558-2017·2017-04-05

    Recall of Regard Sterile Breast PK Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation Llc is recalling 14 kits of Regard sterile breast PK procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU
    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-1664-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 162 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1621-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 284 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1651-2017·2017-04-05

    Recall of Regard Vascular Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 164 sterile vascular procedure trays because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states