The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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22976–23000 of 27699

  • HighFDA (Devices)·Z-2552-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY PK 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-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-2569-2015·2015-09-09

    Customed Wound Management Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,248 wound management trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    WOUND MANAG.TRAY 24/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-2622-2015·2015-09-09

    Customed Angiography Packs Recalled for Sterilization Process Validation Deficiencies

    Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ANGIOGRAPHY PACK CUSTOMED 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-2708-2015·2015-09-09

    Customed Urology Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 155 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UROLOGY 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-2507-2015·2015-09-09

    Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.

    Product
    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2511-2015·2015-09-09

    Halyard NovaPlus Trach Care Closed Suction System Thumb Valve Recall

    Halyard Health is recalling NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2510-2015·2015-09-09

    Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway safety.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2015·2015-09-09

    C.R. Bard Recalls Magic3 Intermittent Catheters Due to Sterile Barrier Breach

    C.R. Bard is recalling 8,970 Magic3 Intermittent Catheters because the sterile barrier packaging may be breached, potentially compromising sterility.

    Product
    Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2523-2015·2015-09-09

    Halyard KimVent Pediatric Closed Suction System Thumb Valve Defect Recall

    Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.

    Product
    KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2015·2015-09-09

    Customed Retina Pack Recall Due to Sterilization Validation Issues

    Customed, Inc. is recalling 21 units of Retina Pack 7/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    RETINA PACK 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-2703-2015·2015-09-09

    Customed Skin Staple Remover Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,180 Skin Staple Remover Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SKIN STAPLE REMOVER KIT 80/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-2682-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 78 units of Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY 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-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-2719-2015·2015-09-09

    Siemens Syngo.plaza PACS Recalled for Potential Data Loss and Mix-ups

    Siemens Medical Solutions is recalling 37 Syngo.plaza PACS units due to a potential issue that could lead to data loss and patient data mix-ups.

    Product
    Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2685-2015·2015-09-09

    Customed Gauze Sponges Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) 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-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-2696-2015·2015-09-09

    Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues

    Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.

    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 wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2568-2015·2015-09-09

    Customed Neuro Pack 3/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 15 packs of NEURO PACK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    NEURO 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-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-2679-2015·2015-09-09

    Customed Minor Laparotomy Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 675 Minor Laparotomy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    MINOR LAPAROTOMY 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