The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 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 988 (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.

2726–2750 of 3429

  • HighFDA (Devices)·Z-2611-2015·2015-09-09

    Customed Mayo Stand Covers Recalled for Sterilization Process Defects

    Customed, Inc. is recalling 540 units of Mayo Stand Covers due to inadequate validation of sterilization processes and package integrity.

    Product
    MAYO STAND COVER W/CSR WRAP 30/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-2694-2015·2015-09-09

    Customed Recalls O.R. Towels Due to Sterilization Process Validation Issues

    Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.

    Product
    O.R. TOWELS 25/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-2690-2015·2015-09-09

    Customed Laparoscopy GYN PK CS/4 Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY GYN 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-2624-2015·2015-09-09

    Customed Femoral Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 152 units of Femoral Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    FEMORAL 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-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-2673-2015·2015-09-09

    Customed Major Lap Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    MAJOR LAP 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-2653-2015·2015-09-09

    Customed Medical Device Recall for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    REEMPLAZO DE RODILLA Y CADERA 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-2665-2015·2015-09-09

    Customed Tummy Tuck Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    TUMMY TUCK PACK-FJG 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-2637-2015·2015-09-09

    Customed Urology Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY 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-2698-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN 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-2571-2015·2015-09-09

    Customed Laparoscopic OB GYN Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSC. OB GYN 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-2532-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. This Class II recall affects a specific lot distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2015·2015-09-09

    Customed Shoulder Pack Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    SHOULDER PACK CUSTOMED 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-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-2573-2015·2015-09-09

    Customed Wound Management Tray II Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 690 Wound Management Tray II units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    WOUND MANAGEMENT TRAY II 30/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-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-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-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-2590-2015·2015-09-09

    Customed Laparotomy Kits Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROTOMY 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-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-2629-2015·2015-09-09

    Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects

    Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.

    Product
    NEURO 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-2713-2015·2015-09-09

    Customed recalls cataract packs due to sterilization validation issues

    Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.

    Product
    CATARACT PACK 6/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-2616-2015·2015-09-09

    Customed Recalls Sterile Surgical Kits Due to Sterilization Validation Issues

    Customed, Inc. is recalling 248 units of sterile surgical kits in Puerto Rico because the sterilization processes and package integrity were not adequately validated.

    Product
    HIGADO Y PANCREA 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