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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21851–21875 of 27699

  • HighFDA (Devices)·Z-1411-2016·2016-04-20

    Customed Tracheostomy Care Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 2,800 tracheostomy care kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT 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-1432-2016·2016-04-20

    Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 15 units of Labor and Delivery Surgical Packs due to inadequate sterilization validation and package integrity concerns.

    Product
    Catalog Number: 900168 LABOR & DELIVERY 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-1382-2016·2016-04-20

    GE Healthcare Recalls Aisys Carestation Anesthesia Devices Due to Bolus Issue

    GE Healthcare is recalling Aisys Carestation anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.

    Product
    GE Healthcare, Aisys Carestation.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1483-2016·2016-04-20

    Customed Fan Fold Sheets Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 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-1381-2016·2016-04-20

    GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue

    GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.

    Product
    GE Healthcare, Aisys CS2 anesthesia..
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1383-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1408-2016·2016-04-20

    Customed Peri-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 30 Peri-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001061 PERI-GYN 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-1421-2016·2016-04-20

    Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 81 Neuro-Spine Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001300 NEURO-SPINE 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-1368-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues

    ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2016·2016-04-20

    Customed Minor Procedure Surgical Packs Recalled for Sterilization Defects

    Customed, Inc. is recalling 40 units of Minor Procedure Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900052 MINOR PROCEDURE 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-1409-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001062 ARTHROSCOPY 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-1461-2016·2016-04-20

    Customed Basic Surgical Packs Recalled for Sterilization Validation Defects

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

    Product
    Catalog Number: 9002829 BASIC SURG 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-1372-2016·2016-04-20

    Maquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk

    Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.

    Product
    HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2016·2016-04-20

    Customed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 140 Cystoscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900080 CYSTOSCOPY 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-1377-2016·2016-04-20

    Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

    Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.

    Product
    da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2016·2016-04-20

    Customed Neurosurgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 neurosurgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002256 NEUROSURGERY 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-1420-2016·2016-04-20

    Customed Premium Arthroscopy Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 85 Premium Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001298 PREMIUM ARTHROSCOPY 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-1386-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal

    Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2016·2016-04-20

    Natus Medical Recalls Medix NatalCare ST-LX Neonatal Incubators

    Natus Medical is recalling Medix NatalCare ST-LX neonatal incubators because defective hinge assemblies may cause ports to detach.

    Product
    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2016·2016-04-20

    Customed Recalls Sterile Surgical Towels Due to Sterilization Validation Issues

    Customed, Inc. is recalling 125 sterile surgical towels distributed in Puerto Rico because the sterilization process and package integrity were not adequately validated.

    Product
    Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE 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-1465-2016·2016-04-20

    Customed Surgical Gowns Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL 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-1441-2016·2016-04-20

    Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects

    Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002123 KNEE ARTHROSCOPY 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-1455-2016·2016-04-20

    Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002618 OPEN HEART 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-1384-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 200 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2016·2016-04-20

    Customed Cesarean Section Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 48 Cesarean Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900403 CESAREAN SECTION 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