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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21526–21550 of 40175

  • ModerateFDA (Devices)·Z-0621-2019·2018-12-26

    Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance

    Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.

    Product
    Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0611-2019·2018-12-26

    Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.

    Product
    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2019·2018-12-26

    Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance

    Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.

    Product
    Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0640-2019·2018-12-26

    Advanced Instruments Recalls GloCyte RBC Reagent Due to QC Failure

    Advanced Instruments, LLC is recalling GloCyte RBC Reagent because high fluorescent counts cause quality control checks to fail, preventing patient sample testing.

    Product
    GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors

    Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging lists incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2019·2018-12-26

    COVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve

    COVIDIEN LLC is recalling 32,071 units of 8Fr Argyle Suction Catheter Kits with Chimney Valve, Model 36826, because they were distributed while subject to importation refusal.

    Product
    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0632-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.

    Product
    VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2019·2018-12-26

    Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error

    Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.

    Product
    Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0655-2019·2018-12-26

    Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding

    Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.

    Product
    RT-5100 Refractor, a component of the Epic-5100 System.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0642-2019·2018-12-26

    Zimmer Biomet Compress System Surgical Technique Correction Recall

    Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.

    Product
    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2019·2018-12-19

    Arjo Passive Clip Sling Recalled for Material Breakage Risk

    ArjoHuntleigh is recalling 10 units of Passive Clip Slings because the material may break during patient transfers, posing a risk of falls and serious injury.

    Product
    ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0606-2019·2018-12-19

    GE Healthcare Recalls Discovery NM/CT 670 DR Due to Electrical Hazard

    GE Healthcare is recalling four Discovery NM/CT 670 DR units because incorrect wiring of safety switches may prevent the system from shutting off power, creating an electrical hazard.

    Product
    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and…
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0581-2019·2018-12-19

    Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0598-2019·2018-12-19

    Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure

    Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.

    Product
    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0585-2019·2018-12-19

    GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk

    GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2019·2018-12-19

    GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk

    GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.

    Product
    B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2019·2018-12-19

    Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.

    Product
    Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0584-2019·2018-12-19

    GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk

    GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.

    Product
    PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal…
    Category
    Medical Device
    Distribution
    Distributed nationwide