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.

76–100 of 124

  • HighFDA (Devices)·Z-1548-201·2017-04-05

    Recall of Regard Ortho Pk Spohn Custom Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 2,122 Regard Ortho Pk Spohn custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
    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
  • 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-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-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-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-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-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
  • HighFDA (Devices)·Z-1553-2017·2017-04-05

    Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 420 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
    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-1657-2017·2017-04-05

    FDA Recalls 216 Spohn Laparoscopy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 216 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • 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-1586-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 48 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
    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-1660-2017·2017-04-05

    FDA Recalls Sterile Vaginal Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 56 sterile major vaginal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1678-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 660 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1554-2017·2017-04-05

    Recall of Regard Sterile C Section Packs Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 320 sterile C Section Packs because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
    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-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-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-1551-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 112 sterile Spohn Shoulder System kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
    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-1549-2017·2017-04-05

    Recall of Regard Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 208 Regard Total Joint Procedure Kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
    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-1628-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 384 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states