The Recall Desk

Hazard

Sterilization Failure recalls

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

What the numbers show

Total
574
Critical
3
Severe
34
Most recent
2026-07-22

Of the 574 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (6%) 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 sterilization failure 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.

501–525 of 574

  • HighFDA (Devices)·Z-2700-2015·2015-09-09

    Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 639 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ORTHO-IMPLANT SURGICAL PACK, 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-2640-2015·2015-09-09

    Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 304 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY PACK 4/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-2625-2015·2015-09-09

    Customed Lithotomy Pack Recall Due to Sterilization Validation Issues

    Customed, Inc. is recalling 370 units of Lithotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LITHOTOMY PACK 10/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-2587-2015·2015-09-09

    Customed E.N.T. PK 7/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 63 units of E.N.T. PK 7/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    E.N.T. PK 7/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-2659-2015·2015-09-09

    Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs distributed in Puerto Rico due to inadequate sterilization process validation and package integrity concerns.

    Product
    ORTHOPEDIC PACK BASIC 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-2715-2015·2015-09-09

    Customed Laparotomy Pack Recall Due to Sterilization Validation Issues

    Customed, Inc. is recalling 243 units of Laparotomy Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY PACK 3/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-2623-2015·2015-09-09

    Customed Knee Arthroscopy Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 188 Knee Arthroscopy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    KNEE ARTHROSCOPY PK 4/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-2686-2015·2015-09-09

    Customed Laparotomy Basic Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 units of Laparotomy Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY BASIC PACK 10/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-2670-2015·2015-09-09

    Customed Basic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 77 units of Basic Packs Without Gown due to inadequate validation of sterilization processes and package integrity.

    Product
    BASIC PACK W/OUT GOWN 11/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-2701-2015·2015-09-09

    Customed Recalls Carpal Tunnel Surgical Packs Due to Sterilization Issues

    Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    CARPAL TUNEL LARGE SURGICAL 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-2711-2015·2015-09-09

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 105 Plastic Surgery Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PLASTIC SURGERY 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-2636-2015·2015-09-09

    Customed EENT Pack I Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling EENT Pack I sterile medical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    EENT PACK I (1) 10/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-2674-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 490 Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN PACK 2/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