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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19276–19300 of 27682

  • HighFDA (Devices)·Z-3050-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 367 ORA Systems with VerifEye because a software error may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3060-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 100 Due to Seal Integrity

    Shippert Medical Technologies is recalling Tissu-Trans Filtron 100 units because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3057-2017·2017-08-30

    Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure

    Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.

    Product
    Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3056-2017·2017-08-30

    Medtronic Fusion ENT Instrument Kit Recalled for Verification Failure

    Medtronic is recalling 15 Fusion ENT Instrument Kits because the instruments fail pre-use verification. The kits were distributed in the US and Canada.

    Product
    Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3038-2017·2017-08-23

    Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 9,200 Emblem MRI S-ICD devices because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3034-2017·2017-08-23

    Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

    Cenorin, LLC is recalling 18 ThermaSure Series 1000 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

    Product
    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3039-2017·2017-08-23

    Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption

    Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3037-2017·2017-08-23

    Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.

    Product
    EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2017·2017-08-23

    Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

    Cyberonics is recalling 396 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause the devices to lose power faster than expected.

    Product
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3032-2017·2017-08-23

    Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

    Cenorin, LLC is recalling 34 ThermaSure Series 130 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

    Product
    ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3028-2017·2017-08-23

    GE MRI Scanners Recalled for Potential Power Supply Shock Hazard

    GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.

    Product
    1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3022-2017·2017-08-23

    GE Medical Systems Recalls Optima MR450 1.5T Scanners for Wiring Defect

    GE Medical Systems is recalling 68 Optima MR450 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3041-2017·2017-08-23

    Baxter HomeChoice Pro Automated Peritoneal Dialysis System Recall

    Baxter is recalling HomeChoice Pro Automated PD systems because damaged cassettes may allow air delivery to patients.

    Product
    HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3025-2017·2017-08-23

    GE Medical Systems Recalls Discovery MR750 3.0T Scanners for Shock Hazard

    GE Medical Systems is recalling 68 Discovery MR750 3.0T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3026-2017·2017-08-23

    GE Medical Systems Recalls MRI Scanners Due to Power Supply Wiring

    GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2017·2017-08-23

    GE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring

    GE Medical Systems is recalling 68 Brivo MR355 and Optima MR360 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.

    Product
    Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3024-2017·2017-08-23

    GE Optima MR450w 1.5T MRI Scanner Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Optima MR450w 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3027-2017·2017-08-23

    GE Signa MRI Systems Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Signa MRI systems due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3031-2017·2017-08-23

    ICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk

    ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.

    Product
    Plum 360 Infusion System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3018-2017·2017-08-23

    Exactech Recalls Truliant Tibial Trial Handles Due to Pin Disassociation Risk

    Exactech is recalling 68 Truliant Tibial Trial Handles because the pin may disassociate from the main body. The devices were distributed to 11 states.

    Product
    Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-3042-2017·2017-08-23

    C.R. Bard Recalls Arctic Sun 5000 Temperature Management Systems

    C.R. Bard is recalling 3,450 Arctic Sun 5000 Temperature Management Systems due to potential failure if used for more than 2,000 hours without preventive maintenance.

    Product
    Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3035-2017·2017-08-23

    Magellan LeadCare II Blood Lead Test Kit Recall for Out-of-Range Controls

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because the lead controls were out of range. The recall affects 12,931 kits distributed worldwide.

    Product
    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3029-2017·2017-08-23

    GE Medical Systems Recalls Signa PET/MR Systems Due to Shock Hazard

    GE Medical Systems is recalling 68 Signa PET/MR systems because possible incorrect wiring of the Uninterruptable Power Supply could contribute to a potential shock hazard.

    Product
    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3040-2017·2017-08-23

    Baxter HomeChoice Automated PD System Recalled for Air Delivery Risk

    Baxter is recalling HomeChoice Automated PD systems because damaged cassettes may allow the device to deliver air to patients.

    Product
    HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3023-2017·2017-08-23

    GE Optima MR750 MRI Scanner Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Optima MR750 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal…
    Category
    Medical Device
    Distribution
    Distributed nationwide