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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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

26526–26550 of 27722

  • HighFDA (Devices)·Z-1405-2013·2013-06-05

    AngioDynamics Recalls Micro Introducer Kits Due to Potential Size Mismatch

    AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.

    Product
    AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2013·2013-06-05

    RayStation Therapy Treatment Planning System Recalled for Image Offset Errors

    RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.

    Product
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1404-2013·2013-06-05

    Canon RK-F2 Ref-Keratometer Recalled for Abnormal Refractive Power Readings

    Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.

    Product
    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2013·2013-06-05

    Fisher & Paykel Recalls ICON CPAP Units Due to Power Issue

    Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.

    Product
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2013·2013-06-05

    Heart Sync Recalls Radiotransparent Defibrillation Electrodes Due to Equipment Damage

    Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.

    Product
    Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1433-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2013·2013-06-05

    Heart Sync C100-Physio Defibrillation Electrodes Recalled for Potential Energy Delivery Failure

    Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.

    Product
    Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1438-2013·2013-06-05

    TZ Medical Recalls Defibrillation Electrodes Due to Defective White Wire

    TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.

    Product
    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2013·2013-06-05

    Alphatec Recalls Leucadia Autolok Pedicle Screw System Due to Tolerancing Issue

    Alphatec Spine is recalling the Leucadia Autolok Polyaxial Pedicle Screw System because a tolerancing issue may prevent the rod from locking rigidly, potentially compromising spinal stability.

    Product
    Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2013·2013-06-05

    Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues

    Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.

    Product
    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2013·2013-06-05

    Beckman Coulter Recalls AU2700 and AU5400 Clinical Chemistry Analyzers

    Beckman Coulter is recalling AU2700 and AU5400 Clinical Chemistry Analyzers because tubing connections may leak concentrated detergent.

    Product
    AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2013·2013-06-05

    PTS Glucose Test Strips Recalled for Under-Recovery of Glucose

    Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.

    Product
    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2013·2013-05-29

    Separation Technology Recalls SlidePrep Plus Cytology Centrifuges for Unexpected Startup

    Separation Technology, Inc. is recalling SlidePrep Plus Cytology Centrifuges manufactured before January 1, 2013, because they may start up unexpectedly when exposed to electrostatic discharge.

    Product
    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2013·2013-05-29

    Roche Cobas 8000 Software Recall for Incorrect Immunoassay Results

    Roche Diagnostics is recalling software for the cobas e 602 module because it may produce incorrect test results under specific conditions.

    Product
    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2013·2013-05-29

    Medical Information Technology Recalls Bi-Directional Communication Analyzer Interface

    Medical Information Technology, Inc. is recalling 56 MEDITECH Bi-Directional interactive Communication Analyzer Interface devices due to incorrect transmission of laboratory results.

    Product
    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1346-2013·2013-05-29

    Roche Recalls cobas 4800 Systems Due to Rare Channel Shift Errors

    Roche Molecular Systems is recalling 425 cobas 4800 systems because rare channel-shift errors may cause test results to be reported in the wrong channel.

    Product
    cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrodes

    Progressive Medical is recalling PTFE coated laparoscopic electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide