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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6426–6450 of 27364

  • HighFDA (Devices)·Z-0670-2024·2024-01-17

    Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.

    Product
    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0702-2024·2024-01-17

    H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label

    Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.

    Product
    Detector H. Pylori, Catalog Number IHP-30
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0706-2024·2024-01-17

    XScribe Cardiac Stress Testing System may distort ECG readings

    Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.

    Product
    XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0707-2024·2024-01-17

    Cardiac Stress Testing Device May Produce Distorted ECG Readings

    The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.

    Product
    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT Q
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0698-2024·2024-01-17

    Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects

    Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.

    Product
    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2024·2024-01-17

    Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit

    Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2024·2024-01-17

    Abbott Alinity c Chemistry Analyzer Contains Unlabeled Latex Subcomponent

    Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.

    Product
    Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinit
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0705-2024·2024-01-17

    Cardiac Stress Testing System may produce distorted electrocardiogram readings

    The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.

    Product
    Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0678-2024·2024-01-17

    Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance

    Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.

    Product
    BrightView X, Gamma Camera, Product Code 882478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2024·2024-01-17

    Medline Surgical Gowns Recalled for Manufacturing Defect in Sleeves

    Medline is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 surgical gowns because they were manufactured with the wrong sleeve. The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin.

    Product
    Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0683-2024·2024-01-17

    Sensis Vibe Hemo Medical Device Software May Crash

    Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.

    Product
    Sensis Vibe Hemo
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0679-2024·2024-01-17

    Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard

    Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.

    Product
    BrightView XCT, Gamma Camera, Product Code 882482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2024·2024-01-17

    Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope

    Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2024·2024-01-17

    Abiomed Introducer Kit recalled due to sterile barrier compromise risk

    Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.

    Product
    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2024·2024-01-17

    VISERA Cysto-Nephro Videoscope Model CYF-V2: Reusable Brush Cleaning Update

    Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.

    Product
    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2024·2024-01-17

    MRI systems at risk of unintended magnet shutdown during power loss

    Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.

    Product
    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0671-2024·2024-01-17

    SPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk

    Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.

    Product
    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0647-2024·2024-01-17

    Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise

    Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.

    Product
    Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2024·2024-01-17

    Abiomed Introducer Kits recalled due to sterile barrier compromise

    Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.

    Product
    Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2024·2024-01-17

    Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard

    Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.

    Product
    BrightView, Gamma Camera System, Product Code 882480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2024·2024-01-17

    VADER Pedicle System Torque Wrench Recalled Due to Defective Tightening Function

    Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.

    Product
    VADER pedicle system, torque wrench, Catalog Number 42-703
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0669-2024·2024-01-17

    Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information

    Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.

    Product
    Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2024·2024-01-17

    Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates

    Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.

    Product
    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2024·2024-01-17

    Baxter Preveleak Surgical Sealant recall for inaccurate marketing brochure

    Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.

    Product
    Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0653-2024·2024-01-17

    Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier

    Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.

    Product
    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
    Category
    Medical Device
    Distribution
    Distributed nationwide