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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31351–31375 of 40325

  • LowFDA (Devices)·Z-0540-2016·2015-12-30

    Ameditech RealityCHECK Tilt Cup Benzodiazepine Test Recall

    Ameditech is recalling 80 kits of RealityCHECK Tilt Cup 12 Panel + Adult tests due to reduced reactivity for two benzodiazepine compounds.

    Product
    RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0487-2016·2015-12-30

    Ameditech 11 Panel Card Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 50 kits of the 11 Panel Card (OPI 300) w/Adult because the tests showed reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0519-2016·2015-12-30

    Ameditech ProScreen 10 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0501-2016·2015-12-30

    Ameditech Benzodiazepine Drug Test Recall for Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet drug tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    EDI BZO Uncut Sheet - Cup*, Item No. 160170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0457-2016·2015-12-30

    BC Group International Recalls Defibrillator and Pacer Analyzer Units

    BC Group International is recalling five DA-2006P Defibrillator / Pacer Analyzer units because reversed wires cause inverted waveforms.

    Product
    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0360-2016·2015-12-23

    Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure

    Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.

    Product
    Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0443-2016·2015-12-23

    Remel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs

    Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.

    Product
    Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0394-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure

    Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0393-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure

    Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2016·2015-12-23

    Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction

    Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.

    Product
    MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0414-2016·2015-12-23

    GE Healthcare Optima IGS 320 Recall for Loss of Displayed Imaging

    GE Medical Systems is recalling 45 Optima IGS 320 systems due to a potential safety issue involving non-recoverable loss of displayed imaging.

    Product
    GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2016·2015-12-23

    Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error

    Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.

    Product
    VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0415-2016·2015-12-23

    MOOG Medical Devices Recalls EnteraLite Infinity Enteral Pump Delivery Sets

    MOOG Medical Devices Group is recalling EnteraLite Infinity Enteral Pump Delivery Sets because the purple ENFit connector may crack or break, causing leaks.

    Product
    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0417-2016·2015-12-23

    Stryker Guidewire Introducer Needles Recalled for Expiration Date Issues

    Stryker is recalling 120 units of Guidewire Introducer Needles shipped after expiration or with minimal time remaining due to infection risk.

    Product
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2016·2015-12-23

    Teleflex Medical Recalls Hudson RCI Adult Universal Ventilator Circuits

    Teleflex Medical is recalling 2,600 Hudson RCI Adult Universal Ventilator Circuits because the inspiratory and expiratory tubes are transposed.

    Product
    Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0420-2016·2015-12-23

    Verathon GlideScope Video Laryngoscope Blades Recalled for Potential Separation

    Verathon is recalling GlideScope Video Laryngoscope blades because silicone adhesive may fail, causing the blade halves to separate during use.

    Product
    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error

    bioMerieux, Inc. is recalling MYLA Clinic Patch 3.2.0 CD software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error

    bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2016·2015-12-23

    Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors

    Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a…
    Category
    Medical Device
    Distribution
    Distributed nationwide