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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24076–24100 of 40299

  • HighFDA (Devices)·Z-1458-2018·2018-05-09

    Siemens SOMATOM Sensation 40 CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation 40 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

    Product
    SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1590-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns

    Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2018·2018-05-09

    Radiometer AQURE Software Recalled for Potential Patient Data Mix-Up

    Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1 due to a potential problem that may result in patient mix-up.

    Product
    AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Single Use Probes for Sterility Concerns

    Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.

    Product
    StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2018·2018-05-09

    Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

    Zimmer Biomet is recalling 30 modular hip head components because two lots of different sizes were potentially commingled. This error could lead to the use of an incorrect sized head, causing surgery delays or dislocation.

    Product
    Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2018·2018-05-09

    Siemens SOMATOM Sensation Cardiac CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1594-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Sterilization Caps Due to Sterility Concerns

    Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.

    Product
    StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2018·2018-05-09

    Siemens Biograph Horizon PET/CT Scanner Software Recall for Image Errors

    Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.

    Product
    Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2018·2018-05-09

    Roche cobas b 221 AutoQC Module Recall for Software Failure

    Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.

    Product
    cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2018·2018-05-09

    Beijing Syntech Laser APOLLO JV+ Medical Platform Recalled for Missing Label

    Beijing Syntech Laser is recalling six APOLLO JV+ Medical Platform surgical lasers because the required certification label was not affixed to the products.

    Product
    Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1492-2018·2018-05-09

    Beijing Syntech Laser APOLLO V+ Medical Platform Recalled for Missing Label

    Beijing Syntech Laser Co., Ltd is recalling 11 APOLLO V+ Medical Platform surgical lasers because the required certification label was not affixed to the product.

    Product
    Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1610-2018·2018-05-09

    Roche Omni S2 Analyzer Recall Due to Software Failure

    Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.

    Product
    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2018·2018-05-09

    Beaver-Visitec Recalls Osher Thermodot Markers Due to Incorrect Tip

    Beaver-Visitec is recalling 110 Osher Thermodot Markers because they were manufactured with a needle tip instead of the proper flat tip.

    Product
    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1628-2018·2018-05-09

    Teleflex Laryngo-Tracheal Mucosal Atomization Device Recalled for Labeling Defects

    Teleflex Medical is recalling 25 units of the LMA MADgic device due to missing or incomplete information on the package label.

    Product
    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1611-2018·2018-05-09

    Roche OMNI S4 Analyzer Recalled for Software Scheduler Failure

    Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.

    Product
    Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2018·2018-05-09

    Stryker 6376 M-1 Cot Fastener Recalled for Missing Manual Warnings

    Stryker is recalling 59 M-1 Cot Fasteners distributed to the Netherlands because their operation and maintenance manuals are missing warnings and contain incorrect information.

    Product
    6376 M-1 Cot Fastener, catalog no. 6376000000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1586-2018·2018-05-09

    Siemens Atelia IM 1300 Analyzer Recalled for Reporting Factor Errors

    Siemens Healthcare Diagnostics is recalling Atelia IM 1300 Analyzers because reporting and conversion factors may not apply to all units when connected to a single solution system.

    Product
    Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1543-2018·2018-05-09

    PTS CHOL+GLU Test Strips Recalled for Potential Loss of Glucose Activity

    Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips due to a potential loss of glucose analyte activity before the stated shelf life.

    Product
    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1545-2018·2018-05-09

    BD MAX DNA MMK Lab Use Recalled for Incorrect Package Insert Volume

    Becton Dickinson is recalling BD MAX DNA MMK Lab Use because the package insert incorrectly lists the diluent volume, which could affect assay results.

    Product
    BD MAX DNA MMK Lab Use, catalog no. 442828
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1627-2018·2018-05-09

    Nanosil Spray Gel Recalled for Manufacturing Deficiencies and Missing Expiration Dates

    Conseal International is recalling 384 units of Nanosil Spray Gel due to FDA inspection findings of manufacturing deficiencies and missing expiration dates.

    Product
    Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1583-2018·2018-05-09

    DeRoyal SURGI MATE Electrosurgical Pencils Recalled for Sterility Labeling Error

    DeRoyal Industries is recalling 1,800 non-sterile electrosurgical pencils that were incorrectly labeled as sterile. The affected units were distributed to Honduras, Belgium, and The Netherlands.

    Product
    DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1584-2018·2018-05-09

    CooperSurgical Recalls 5 mm Apple-Hunt Secondary Cannulas Due to Packaging Error

    CooperSurgical, Inc. is recalling 520 units of 5 mm Apple-Hunt Secondary Cannulas because they were packaged with the wrong trocar length type.

    Product
    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide