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 deaths or serious injuries are reported, 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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4901–4925 of 13543

  • ModerateFDA (Devices)·Z-0041-2025·2024-10-16

    Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch

    Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.

    Product
    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0001-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk

    Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.

    Product
    MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-3208-2024·2024-10-09

    Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency

    Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.

    Product
    Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact

    MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.

    Product
    MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809,
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-3207-2024·2024-10-09

    Percussionaire IPV In-Line Valve Recall: Blue Cap Removal Labeling Update

    Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.

    Product
    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0004-2025·2024-10-09

    Neo-Tee T-Piece Resuscitator circuit flow controller may come apart

    Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.

    Product
    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0003-2025·2024-10-09

    MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact

    Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.

    Product
    MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-3309-2024·2024-10-09

    Stryker Tornier Shoulder Implant Insert May Not Seat Securely

    Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.

    Product
    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3313-2024·2024-10-09

    Alcon contact lenses recalled for manufacturing quality defect

    Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.

    Product
    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-3310-2024·2024-10-09

    BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect

    CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.

    Product
    BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3311-2024·2024-10-09

    Contact lenses with misaligned axis may cause poor visual acuity

    CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.

    Product
    Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3304-2024·2024-10-09

    ADVIA Centaur aTPO Assay kits recalled due to positive result bias

    Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.

    Product
    ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2025·2024-10-09

    Philips IntelliVue G7m Anesthesia Gas Module Pump Failure

    Philips IntelliVue G7m Anesthesia Gas Modules may have a faulty sample gas pump that could stop working, interrupting gas measurement. Affected devices have serial numbers DE43800129 through DE43812627.

    Product
    IntelliVue G7m Anesthesia Gas Module, Product Number 866173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2025·2024-10-09

    BD FACSDuet Sample Preparation System software defect causes inaccurate specimen volumes

    The BD FACSDuet sample preparation system may dispense specimen volumes that are 3% to 20% higher in one tube versus another, leading to inaccurate blood counts, delayed test results, and potential additional blood collection. The defect affects 130 systems distributed across the US and internationally.

    Product
    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-3303-2024·2024-10-09

    Urinalysis reagent strips recalled for reduced protein detection sensitivity

    Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.

    Product
    Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2025·2024-10-09

    Dental Ultrasonic Cleaner Recalled for Bacterial Contamination

    Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.

    Product
    BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0019-2025·2024-10-09

    Hemodialysis console blood leak sensor may fail to trigger alarm

    A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.

    Product
    Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0006-2025·2024-10-09

    Miami J Select Collar Recalled Due to Adhesive Failure

    Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.

    Product
    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-3305-2024·2024-10-09

    Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.

    Product
    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3312-2024·2024-10-09

    Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring

    Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.

    Product
    DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3308-2024·2024-10-09

    DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization

    DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.

    Product
    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3307-2024·2024-10-09

    DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

    The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

    Product
    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3306-2024·2024-10-09

    DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization

    The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.

    Product
    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3134-2024·2024-10-02

    Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk

    Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states