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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

22976–23000 of 40175

  • HighFDA (Devices)·Z-2576-2018·2018-08-08

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error

    Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.

    Product
    Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2565-2018·2018-08-08

    Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2018·2018-08-08

    Siemens SOMATOM Scope Power Recalled for Software Radiation Risk

    Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Scope Power (Model 10967888)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2018·2018-08-08

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Radiation Risk

    Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Emotion 16 (10165977)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2018·2018-08-08

    QIAGEN Recalls EZ1 DSP Virus Kit Due to Underfilled Reagent Wells

    QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48) because underfilled reagent wells could lead to incorrect diagnostic results.

    Product
    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2571-2018·2018-08-08

    Cayenne Medical Recalls Quattro Link Drills Due to Breakage Trend

    Cayenne Medical Inc. is recalling 229 Quattro Link drills because a review of complaints identified a trend for the devices breaking.

    Product
    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2570-2018·2018-08-08

    XLTEK EMU40EX EEG Headbox Recalled for Component Degradation

    Natus Neurology is recalling 462 XLTEK EMU40EX EEG Headboxes because an internal electronic component may degrade, causing the unit to overheat and the plastic case to melt.

    Product
    XLTEK EMU40EX EEG Headbox
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2597-2018·2018-08-08

    Baxter Recalls Power Cords for AMIA Automated PD Cycler

    Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.

    Product
    power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2584-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2018·2018-08-08

    Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

    Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2580-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2018·2018-08-08

    Siemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue

    Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Perspective 16 (Model 10891666)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2569-2018·2018-08-08

    Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect

    Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.

    Product
    FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery RT CT systems nationwide due to a potential wiring defect in the electrical panel that may affect the uninterruptible power supply.

    Product
    Discovery RT labeled as: a. MID BJG; b. HVY BJG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2018·2018-08-08

    bioMerieux Recalls VIDAS LH Test Kits Due to Calibration Issues

    bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.

    Product
    VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2591-2018·2018-08-08

    ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures

    ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.

    Product
    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2567-2018·2018-08-08

    Howmedica Custom Implant System Recalled for Missing Instructions

    Howmedica is recalling five custom implant systems because they lacked updated instructions clarifying the locking mechanism and screw warnings.

    Product
    Custom Made Implant System with Minimum Invasive Grower (MIG) component
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2575-2018·2018-08-08

    Randox Liquid Cardiac Control Level 3 Recalled for Precision Issues

    Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.

    Product
    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2590-2018·2018-08-08

    Envoy Medical Recalls Esteem II Sound Processors with Expired Sterile Wipes

    Envoy Medical is recalling four Esteem II Sound Processors because the sterile wipes inside expired before the date labeled on the final pack.

    Product
    Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2600-2018·2018-08-08

    Encore Medical Recalls AltiVate Instrument Trays Due to Coating Issue

    Encore Medical is recalling 30 instrument trays used for AltiVate Small Shell Trials because a black coating may appear after cleaning that is not biocompatible.

    Product
    Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the…
    Category
    Medical Device
    Distribution
    18 states
  • LowFDA (Devices)·Z-2573-2018·2018-08-08

    Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.

    Product
    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
    Category
    Medical Device
    Distribution
    20 states