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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22901–22925 of 27663

  • HighFDA (Devices)·Z-2661-2015·2015-09-09

    Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues

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

    Product
    OBSTETRICAL SURGICAL 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-2554-2015·2015-09-09

    Customed Major Laparotomy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,084 packs of Major Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    MAJOR 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-2605-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 104 units of Cesarean Packs 4/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN 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-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-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-2600-2015·2015-09-09

    Customed Cesarean Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 96 units of Cesarean Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN 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-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-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-2500-2015·2015-09-09

    Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect

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

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2528-2015·2015-09-09

    Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

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

    Product
    KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2015·2015-09-09

    Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 354 units of Laparoscopy-Colorectal Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    LAPAROSCOPY-COLORECTAL SURGICAL 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-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-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-2496-2015·2015-09-09

    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, compromising the closed system.

    Product
    KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2497-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    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* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tracheobronchial suction catheter is a device that is attached to a port of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2522-2015·2015-09-09

    Halyard KimVent Closed Suction Systems Recalled 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* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2492-2015·2015-09-09

    Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect

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

    Product
    KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2015·2015-09-09

    Customed Orthopedic Implants Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 81 orthopedic implants distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    IMPLANTE DE ORTHOPEDIA 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