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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19376–19400 of 27647

  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2017·2017-07-12

    Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming

    Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2684-2017·2017-07-12

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue

    Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.

    Product
    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2688-2017·2017-07-12

    Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation

    Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.

    Product
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2670-2017·2017-07-12

    Smiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects

    Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.

    Product
    Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2685-2017·2017-07-12

    PerkinElmer Multiphor II Electrophoresis System Recalled for Electric Shock Risk

    PerkinElmer is recalling 241 Multiphor II Electrophoresis Systems due to a potential electric shock hazard if grommets are not installed.

    Product
    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2656-2017·2017-07-12

    JAS Diagnostics Recalls Drew Scientific DREW 3-PAC Reagent Kits

    JAS Diagnostics Inc. is recalling 14,064 units of Drew Scientific DREW 3-PAC Reagent Kits because they may result in elevated platelet backgrounds during routine startup checks.

    Product
    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2639-2017·2017-07-05

    DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect

    DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.

    Product
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2017·2017-07-05

    EOS Imaging Recalls ROTH MOBELI Grab Handles for Detachment Risk

    EOS Imaging is recalling ROTH MOBELI grab handles because they could detach, posing a fall risk to patients if operators do not follow instructions.

    Product
    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2629-2017·2017-07-05

    Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage

    Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.

    Product
    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2017·2017-07-05

    Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

    Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2017·2017-07-05

    Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors

    Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.

    Product
    SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2017·2017-07-05

    Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect

    Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.

    Product
    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2017·2017-07-05

    Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2624-2017·2017-07-05

    Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2634-2017·2017-07-05

    Mindray Recalls TI Transport Monitor Battery Packs Due to Overheating

    Mindray is recalling 2,718 TI Transport Monitor battery packs because two reports indicated the packs overheated.

    Product
    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2017·2017-07-05

    Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure

    Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.

    Product
    MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2017·2017-07-05

    Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

    Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2017·2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2017·2017-07-05

    Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector

    Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.

    Product
    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2017·2017-07-05

    Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

    Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

    Product
    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by…
    Category
    Medical Device
    Distribution
    Distributed nationwide