The Recall Desk

Hazard

Infection recalls

2,547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,547
Critical
31
Severe
1,678
Most recent
2026-09-09

Of the 2,547 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,678 (66%) 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 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.

1976–2000 of 2547

  • SevereFDA (Devices)·Z-0359-2015·2014-12-10

    Customed Debridement Tray Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0402-2015·2014-12-10

    Customed Femoral Angiography Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 236 units of Femoral Angiography Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0391-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0253-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 4,710 surgical gowns because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0250-2015·2014-12-10

    Customed Skin Staple Removal Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0321-2015·2014-12-10

    Customed Endovenous Custom Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0301-2015·2014-12-10

    Customed Universal Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Universal Pack, Catalog number 900-1587. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0349-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0297-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0323-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 57 Laparoscopy Packs (Catalog 900-1967) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0294-2015·2014-12-10

    Customed ENT Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0245-2015·2014-12-10

    Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0279-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0263-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 2,240 surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0255-2015·2014-12-10

    Customed Medical Leggings Recalled Due to Compromised Sterility

    Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0324-2015·2014-12-10

    Customed Orthopedic Trays Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0264-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0273-2015·2014-12-10

    Customed Peri Gyn Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 162 units of Peri Gyn Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0350-2015·2014-12-10

    Customed OB Packs Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0254-2015·2014-12-10

    Customed Wound Management Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0258-2015·2014-12-10

    Customed Wound Management Tray Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0390-2015·2014-12-10

    Customed Laparoscopy Gyn Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Laparoscopy Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0260-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0338-2015·2014-12-10

    Customed Total Hysterectomy Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0261-2015·2014-12-10

    Customed Recalls Surgical Gowns Due to Compromised Sterility

    Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.

    Product
    Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states