The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 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 993 (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 3438

  • 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-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-1632-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 46 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1572-2017·2017-04-05

    Recall of Regard Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 22 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1611-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 100 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
    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-1670-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach

    Resource Optimization & Innovation LLC is recalling 32 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    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-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-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-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-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-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-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-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-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-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-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