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-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-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-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-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-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-1616-2017·2017-04-05

    Recall of Pediatric Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 430 sterile pediatric procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1647-2017·2017-04-05

    Recall of Regard Sterile Open Heart Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 228 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
    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
  • HighFDA (Devices)·Z-1633-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 71 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1589-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 344 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1653-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
    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-1577-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 78 sterile laparotomy kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1567-2017·2017-04-05

    Recall of Pacemaker Procedure Kits Due to Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1675-2017·2017-04-05

    Recall of Titanium Rib Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 90 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1656-2017·2017-04-05

    Recall of Robotic Hysterectomy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 249 sterile robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn
    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-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-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-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-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-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-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-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-1629-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states