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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22401–22425 of 27663

  • HighFDA (Devices)·Z-0474-2016·2015-12-30

    Becton Dickinson Recalls Enterococcus Screen Agar QUAD Plates

    Becton Dickinson is recalling 770 units of Enterococcus Screen Agar QUAD Plates due to potential breakthrough growth of Enterococcus faecalis near the end of shelf life.

    Product
    Enterococcus Screen Agar QUAD Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2016·2015-12-30

    Terumo Recalls Winged Infusion Sets Due to Improper Bonding

    Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.

    Product
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0445-2016·2015-12-30

    CareFusion Recalls Alaris Pump SmartSite Infusion Sets Due to Leakage Risk

    CareFusion is recalling Alaris Pump SmartSite Infusion Sets because disconnection and leakage may occur during infusion.

    Product
    Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2016·2015-12-30

    Zimmer Universal Power System Handpieces Recalled for Malfunction

    Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.

    Product
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0450-2016·2015-12-30

    Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect

    Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.

    Product
    A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
    Category
    Medical Device
    Distribution
    51 states
  • 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
  • HighFDA (Devices)·Z-0413-2016·2015-12-23

    GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

    GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

    Product
    GE Healthcare Optima CL323i 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-0429-2016·2015-12-23

    bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

    bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.1 CLI 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-0438-2016·2015-12-23

    Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction

    Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.

    Product
    MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0447-2016·2015-12-23

    Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure

    Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.

    Product
    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2016·2015-12-23

    Philips Ingenuity Core CT Scanner Software Recall

    Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned during specific protocols.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide