The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection risk 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.

2001–2025 of 3429

  • 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-1595-2017·2017-04-05

    Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 12 kits of Regard sterile procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1643-2017·2017-04-05

    Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
    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
  • 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-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-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-1622-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 148 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
    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-1620-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 120 sterile custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1545-2017·2017-04-05

    Recall of Regard sterile procedure trays due to glove splitting risk

    Resource Optimization & Innovation LLC is recalling 46 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535001, Sterile, LD0620A - 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-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-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-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-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-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-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-1564-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU
    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-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-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-1665-2017·2017-04-05

    Recall of Spohn AV Access Kits Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 306 Spohn AV Access Kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
    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-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