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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24401–24425 of 27663

  • HighFDA (Devices)·Z-2674-2014·2014-10-01

    DePuy Synthes Recalls TI Vectra Plates Due to Missing Clips

    Synthes, Inc. is voluntarily recalling 16 units of TI Vectra Plates because clips may be missing. The plates are used for cervical spine fixation.

    Product
    DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2706-2014·2014-10-01

    Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage

    Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2691-2014·2014-10-01

    Justright Surgical Recalls 5mm Reloads Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Reloads because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2642-2014·2014-09-24

    EMG Technology Recalls Vac-Assist Suction Units Due to Occluded Ports

    EMG Technology is recalling 1,452 Vac-Assist Suction Units because the canister lids may have occluded ports, potentially preventing proper fluid removal.

    Product
    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2637-2014·2014-09-24

    Data Innovations Recalls ProVue Instrument Driver for JResultNet Software

    Data Innovations, LLC is recalling ProVue Instrument Driver for JResultNet versions 1.5.3 and below because the software may misassociate data with patient results.

    Product
    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2014·2014-09-24

    JK Products Recalls Sun Dash Radius 252 Tanning Beds Due to Electrical Hazard

    JK Products & Services is recalling 1,948 Sun Dash Radius 252 tanning beds because excessive flexing of the main electrical cord can compromise wire integrity.

    Product
    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2014·2014-09-24

    Varian 4D Integrated Treatment Console Recall for Safety Interlock Defect

    Varian Medical Systems is recalling 512 4D Integrated Treatment Consoles because user error can allow improper clearing of safety interlocks.

    Product
    4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns

    Bio-Detek is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2014·2014-09-24

    Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors

    Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2567-2014·2014-09-24

    Varian C-Series Linear Accelerators Recalled for Beam Output Decrease

    Varian Medical Systems is recalling C-Series High Energy Linear Accelerators due to a trend of unexpected decreases in beam output during 6MV photon treatment.

    Product
    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2014·2014-09-24

    Volcano TrakBack II Disposable Pullback Device Recalled for Sterility Concerns

    Volcano Corporation is recalling TrakBack II Disposable Pullback Devices because internal testing identified a potential breach to the sterile barrier that may impact product sterility.

    Product
    Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2014·2014-09-24

    Becton Dickinson Recalls Vancomycin Screen Agar Due to False Resistance Results

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the product may allow susceptible bacteria to grow, leading to false resistance test results.

    Product
    BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2660-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2014·2014-09-24

    Siemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias

    Siemens is recalling ADVIA Chemistry A1c_3 Calibrators because they may cause a percent bias in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2014·2014-09-24

    ArjoHuntleigh Recalls Tenor Mobile Passive Lifts Due to Bolt Breakage Risk

    ArjoHuntleigh is recalling Tenor mobile passive lifts because the spreader bar bolt may break during use, posing a risk to patients and caregivers.

    Product
    Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2626-2014·2014-09-17

    Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

    Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

    Product
    Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal…
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2627-2014·2014-09-17

    Stryker Recalls Aria Inserter Devices Due to Product Fracturing

    Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

    Product
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in…
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2608-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2014·2014-09-17

    GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure

    GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.

    Product
    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2609-2014·2014-09-17

    Ab Sciex API 3200MD System Recalled for Incorrect Diagnostic Data

    Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.

    Product
    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2614-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. ****Indications for Use: For the administration of fluids from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2611-2014·2014-09-17

    Illumina Worklist Manager Software Recalled for Performance Failure

    Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.

    Product
    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2014·2014-09-17

    Wright Medical Recalls CLAW II 2 Hole Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 497 CLAW II 2 Hole Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide