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.

476–500 of 574

  • HighFDA (Devices)·Z-2664-2015·2015-09-09

    Customed Face Lift Medical Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 units of Face Lift medical kits due to inadequate validation of sterilization processes and package integrity.

    Product
    FACE LIFT 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-2572-2015·2015-09-09

    Customed Open Heart Trays Recalled for Sterilization Validation Defects

    Customed, Inc. is recalling 106 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-2561-2015·2015-09-09

    Customed Laparoscopic Cholecystectomy Kits Recalled for Sterilization Defects

    Customed, Inc. is recalling 426 laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.

    Product
    LAPAROSC CHOLE 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-2555-2015·2015-09-09

    Customed Minor Procedure Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR PROCEDURE PACK 40/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-2627-2015·2015-09-09

    Customed Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SURGICAL PACK 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-2612-2015·2015-09-09

    Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 546 ophthalmic surgical 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-2681-2015·2015-09-09

    Customed Laparoscopy OB 6/CS Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY OB 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-2654-2015·2015-09-09

    Customed Shoulder Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 177 units of Shoulder Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER 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-2633-2015·2015-09-09

    Customed Ear Packs Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling specific lots of Ear Packs used in surgical procedures 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-2658-2015·2015-09-09

    Customed Basic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 432 Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    BASIC PACK 8/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-2582-2015·2015-09-09

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 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 wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2580-2015·2015-09-09

    Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.

    Product
    PEDIATRIC LAP PACK 8/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-2649-2015·2015-09-09

    Customed Open Heart Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 27 Open Heart Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    OPEN HEART PACK 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-2607-2015·2015-09-09

    Customed Urology PK 5/CS Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 10 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-2693-2015·2015-09-09

    Customed Arthroscopy Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 320 Arthroscopy PK 5/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY 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-2647-2015·2015-09-09

    Customed Extremity Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 285 units of Extremity Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    EXTREMITY 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-2550-2015·2015-09-09

    Customed O.B. PK Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 48 packs of O.B. PK surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. 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-2604-2015·2015-09-09

    Customed O.B. Packs Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. PACK 4/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-2563-2015·2015-09-09

    Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 180 packs of Arthroscopy PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PK CS/4 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-2618-2015·2015-09-09

    Customed Angiography Kits Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 388 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ANGIOGRAPHY 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-2601-2015·2015-09-09

    Customed Labor and Delivery Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 344 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LABOR & DELIVERY 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-2638-2015·2015-09-09

    Customed Minor Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 1,452 units of Minor Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR 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-2704-2015·2015-09-09

    Customed General Minor PK 5/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 425 units of General Minor PK 5/CS surgical kits due to inadequate validation of sterilization processes and package integrity.

    Product
    GENERAL MINOR 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-2592-2015·2015-09-09

    Customed Urology Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 352 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY 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-2556-2015·2015-09-09

    Customed Wound Closure Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 8,050 Wound Closure Tray I units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    WOUND CLOSURE TRAY I 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