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.

1626–1650 of 2547

  • HighFDA (Devices)·Z-2671-2015·2015-09-09

    Customed Recalls Angiodrape Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling Angiodrape Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.

    Product
    ANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2565-2015·2015-09-09

    Customed Tracheotomy Care Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 3,550 Tracheotomy Care Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2689-2015·2015-09-09

    Customed Utility Drapes Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Utility Drapes due to inadequate validation of sterilization processes and package integrity.

    Product
    UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2575-2015·2015-09-09

    Customed Premium Cesarean Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 25 Premium Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PREMIUM CESAREAN PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2549-2015·2015-09-09

    Customed Suture Removal Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 20,200 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2650-2015·2015-09-09

    Customed Face Pack Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 24 units of Face Pack MRT due to inadequate validation of sterilization processes and package integrity.

    Product
    FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2628-2015·2015-09-09

    Customed Ear Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 48 units of Ear Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2593-2015·2015-09-09

    Customed Dressing Change Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,050 units of Dressing Change kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2656-2015·2015-09-09

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2648-2015·2015-09-09

    Customed Shoulder Packs Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2581-2015·2015-09-09

    Customed Open Heart Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2614-2015·2015-09-09

    Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 360 Ophthalmic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2716-2015·2015-09-09

    Customed PERI GYN PACK recalled for sterilization validation issues

    Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS due to inadequate validation of sterilization processes and package integrity.

    Product
    PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2566-2015·2015-09-09

    Customed Foley Catheter Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,960 Foley Catheter Kits II 16FR distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2606-2015·2015-09-09

    Customed Minor Laparotomy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 945 Minor Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2619-2015·2015-09-09

    Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2678-2015·2015-09-09

    Customed Cysto Tur Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2608-2015·2015-09-09

    Customed Urology PK 5/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2621-2015·2015-09-09

    Customed Gauze Recalled Due to Sterilization Validation Deficiencies

    Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2699-2015·2015-09-09

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2626-2015·2015-09-09

    Customed Shoulder Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 327 units of Shoulder Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2657-2015·2015-09-09

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,866 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2651-2015·2015-09-09

    Customed Tummy Tuck and Breast Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2551-2015·2015-09-09

    Customed Irrigation Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 4,800 irrigation trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2645-2015·2015-09-09

    Customed Arthroscopy Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 75 units of Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state