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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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16426–16450 of 27500

  • SevereFDA (Devices)·Z-0625-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2019·2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic 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
  • HighFDA (Devices)·Z-0639-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit

    bioMerieux is recalling VITEK 2 Systems Software Version 9.01 Update Kits because they may display incorrect organism identification and antimicrobial susceptibility testing results.

    Product
    VITEK¿ 2 Systems Software Version 9.01 Update Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS T2X Tables Due to Roll Position Drift

    Deerfield Imaging is recalling 15 IMRIS T2X tables because they may drift in the roll position while in use.

    Product
    IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 300 Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS ORT 300 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0659-2019·2018-12-26

    Konica Minolta Recalls 151 X-Ray Systems Due to Unintentional Movement

    Konica Minolta is recalling 151 Advanced Universal U-Arm 4000 X-ray systems because the U-Arm may move unintentionally.

    Product
    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2019·2018-12-26

    Jarvik 2000 Ventricular Assist System External Cables Recalled for Connector Damage

    Jarvik Heart Inc is recalling 274 external cable components for the Jarvik 2000 Ventricular Assist System due to potential damage to male connectors.

    Product
    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0649-2019·2018-12-26

    Foundation Medicine Recalls 800 FoundationOne CDx Test Reports

    Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.

    Product
    FoundationOne CDx Test Results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2019·2018-12-26

    ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms

    ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.

    Product
    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0647-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 200 Tables Due to Roll Drift

    Deerfield Imaging is recalling 14 IMRIS ORT 200 operating room tables because they may drift in the roll position while in use.

    Product
    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2019·2018-12-26

    bioMerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to False Results

    bioMerieux is recalling VITEK 2 Streptococcus Susceptibility Cards because they may produce false resistant results for specific Streptococcus strains.

    Product
    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2019·2018-12-26

    Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches

    Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.

    Product
    Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2019·2018-12-26

    Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors

    Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.

    Product
    Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0616-2019·2018-12-26

    Siemens Dimension Vista 500 Recalled for Sample Contamination Risk

    Siemens is recalling Dimension Vista 500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2019·2018-12-26

    Bracco Recalls Empower FastLoad CT Syringe Packs Due to Seal Defect

    Bracco is recalling 33,350 Empower FastLoad CT Syringe Packs because an insufficient seal on the sterile barrier may compromise the device's sterility.

    Product
    Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2019·2018-12-26

    Fresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers due to a potential for external blood leaks from the dialyzer header.

    Product
    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2019·2018-12-26

    Mazor Robotics Recalls Carousel Accessories for Brain and Spinal Surgery Kits

    Mazor Robotics is recalling five Carousel MAS1025-01 units used in brain and spinal surgery kits because the position pin may fail, causing the carousel to move inadvertently.

    Product
    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended…
    Category
    Medical Device
    Distribution
    0 states
  • 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