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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3901–3925 of 39824

  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2025·2025-05-21

    Philips Intera CV MRI Quadrature Body Coil Seal Adhesive Failure Recall

    Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.

    Product
    Intera CV, Model Number: 781107;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Failure

    Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.

    Product
    Intera 1.5T Omni/Stellar, Model Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2025·2025-05-21

    Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.

    Product
    Intera 1.0T Omni/Stellar, Model Number: 781102;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2025·2025-05-21

    Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure

    Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 3.0T Quasar Dual, Model Number: 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin injuries.

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall

    Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.

    Product
    Intera 1.5T Master/Nova, Model Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2025·2025-05-21

    Philips SmartPath dStream 1.5T MRI coil may create sharp edges

    Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.

    Product
    SmartPath to dStream for 1.5T, Model Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2025·2025-05-21

    Philips SmartPath to dStream 3.0T MRI Coil Adhesive Failure Recall

    Philips is recalling SmartPath to dStream 3.0T MRI systems (Model 782145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    SmartPath to dStream for 3.0T, Model Number: 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2025·2025-05-21

    Halyard RAPIDES E-PACK Cardiovascular Procedure Kit Surgical Needle Coating Issue

    AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a raw material defect in surgical needle coating that may cause diminished performance or coating removal during use.

    Product
    Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2025·2025-05-21

    Philips Intera 1.5T R11 MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T R11 MRI systems because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could contact patients and cause skin injuries.

    Product
    Intera 1.5T R11, Model Number: 781170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2025·2025-05-21

    Philips Intera 0.5T Standard MRI System Quadrature Body Coil Seal

    Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and create sharp edges that could injure patients during scanning.

    Product
    Intera 0.5T Standard, Model Number: 781101;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2025·2025-05-21

    Philips Enterprise 1.5T MRI Equipment Quadrature Body Coil Seal

    Philips is recalling Enterprise 1.5T MRI scanners (Model 781145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Enterprise 1.5T, Model Number: 781145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2025·2025-05-21

    Abbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.

    Product
    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2025·2025-05-21

    Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals

    LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.

    Product
    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2025·2025-05-21

    BIB Balloon in Balloon Dilatation Catheter labeling error recalled

    Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model Number 420 due to incorrect labeling of balloon inflation hubs. The inner and outer balloon labels are swapped, which could lead to improper device use.

    Product
    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1784-2025·2025-05-21

    Beckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error

    Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to a software error that prevents the analyzer from completing calibration orders under certain conditions, which can delay test result reporting.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriat
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1747-2025·2025-05-21

    FoundationOne Companion Diagnostic reports clinically relevant variants requiring amendment

    Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2025·2025-05-21

    Halyard CHRIST SUTURE KIT surgical needles coating defect recall

    AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.

    Product
    Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2025·2025-05-21

    Centurion Sterile Weitlaner Retractor recalled for packaging puncture risk

    Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.

    Product
    Centurion Sterile Weitlaner Retractor, Reorder: 67315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1745-2025·2025-05-21

    Contour Gold Eyelid Weight implants recalled for mislabeling

    Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3012) due to mislabeling. Thirty-four weights distributed nationwide are affected.

    Product
    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2025·2025-05-21

    Halyard SUTURE PACK CABG Cardiovascular Kit Needle Coating Issue

    AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.

    Product
    Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2025·2025-05-21

    PiezoWave 2 Control Unit therapeutic massager high voltage capacitor failure

    Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Units (Product Number 100506US) due to a high voltage capacitor that may fail early in the device's life cycle, potentially producing smoke, burning smell, spark, or excessive heat.

    Product
    PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1744-2025·2025-05-21

    Contour Gold Eyelid Weight implants recalled for mislabeling

    Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3010, 1.0 gm) due to mislabeling. The recall affects 34 units distributed nationwide across 17 states.

    Product
    Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2025·2025-05-21

    CMS8000 Patient Monitor Has Nine Cybersecurity Vulnerabilities

    The CMS8000 Patient Monitor manufactured by Contec Medical Systems Co., Ltd. has nine identified cybersecurity vulnerabilities. The FDA is issuing this Class II recall affecting approximately 7,773 units distributed nationwide.

    Product
    CMS8000 Patient Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide