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

34751–34775 of 40449

  • ModerateFDA (Devices)·Z-2726-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2719-2014·2014-10-08

    St. Jude Medical Percutaneous Trial Lead Kit Manual Recall

    St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.

    Product
    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2717-2014·2014-10-08

    KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift

    KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.

    Product
    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2712-2014·2014-10-08

    Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect

    Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.

    Product
    The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-2715-2014·2014-10-08

    Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.

    Product
    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2718-2014·2014-10-08

    St. Jude Medical Percutaneous Trial Lead Kit Manual Recall

    St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.

    Product
    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2621-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.

    Product
    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2014·2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from…
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-2620-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. 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
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2593-2014·2014-10-01

    CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

    CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

    Product
    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2698-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during attachment or manipulation.

    Product
    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2014·2014-10-01

    Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting

    Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.

    Product
    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2014·2014-10-01

    Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction

    Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.

    Product
    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2703-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm is recalling 22,042 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2014·2014-10-01

    CareFusion AirLife Heated Infant Breathing Circuit Recalled for Material Change

    CareFusion is recalling approximately 318,280 heated infant breathing circuits due to a regulatory compliance risk involving a material change to the gas pathway.

    Product
    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2700-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 1,005 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2014·2014-10-01

    Siemens Artis zee and zeego X-ray Systems Recalled for Radiation Release Issue

    Siemens is recalling 206 Artis zee and Artis zeego X-ray systems because radiation release can become blocked unnecessarily under certain circumstances.

    Product
    Artis zee and Artis zeego systems. x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2014·2014-10-01

    Genesys Spine Recalls Circular Lock Screws Due to Material Error

    Genesys Orthopedics Systems is recalling 642 Circular Lock Screws from the TiLock Pedicle Screw System because a portion of the lot was manufactured with stainless steel instead of the specified titanium alloy.

    Product
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2694-2014·2014-10-01

    Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues

    Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.

    Product
    eye-pak 7407 Tray Support Cover REF 8065740745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2014·2014-10-01

    ArjoHuntleigh Recalls Minstrel Mobile Passive Hoists Due to Bolt Failure

    ArjoHuntleigh is recalling 18 Minstrel mobile passive hoists because a bolt under the scale may unscrew, posing a risk of the spreader bar detaching during use.

    Product
    Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to…
    Category
    Medical Device
    Distribution
    Distributed nationwide