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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19326–19350 of 27682

  • HighFDA (Devices)·Z-2788-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2017·2017-08-09

    Olympus VANTA Analytical X-Ray System Recalled for Proximity Shutdown Failure

    Olympus is recalling 146 VANTA Analytical X-Ray Systems because they may fail to stop testing when no sample is present.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2017·2017-08-09

    Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk

    Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2783-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2790-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2865-2017·2017-08-09

    SoftLab Software Recalled for Incorrect Lab Result Display

    Soft Computer Consultants is recalling SoftLab Software versions 4.5.4.3 through 4.5.5.20 because it may display lab results based on incorrect LOINC codes.

    Product
    SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2794-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterility Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2736-2017·2017-08-02

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100i Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2737-2017·2017-08-02

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2738-2017·2017-08-02

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.

    Product
    CS 300 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2017·2017-08-02

    Invuity PhotonBlade Recalled for Potential Unintended Energy Discharge

    Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.

    Product
    INVUITY(R) PhotonBlade(TM), REF PB1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2017·2017-08-02

    Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2017·2017-08-02

    Fisher Diagnostics Recalls FDP Assay Kits Due to False Negative Risk

    Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.

    Product
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For…
    Category
    Medical Device
    Distribution
    Distributed nationwide