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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24001–24025 of 40175

  • 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
  • ModerateFDA (Devices)·Z-1612-2018·2018-05-09

    Roche OMNI S6 Analyzer Software Defect Recalled by FDA

    Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.

    Product
    cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 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-1589-2018·2018-05-09

    Philips Allura Xper and UNIZ Systems Recalled for Monitor Freezing

    Philips is recalling 682 Allura Xper and UNIZ interventional fluoroscopic x-ray systems because the large screen monitor may freeze for 15 seconds after continuous operation.

    Product
    Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging…
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1494-2018·2018-05-09

    Beijing Syntech Laser surgical lasers recalled for missing certification label

    Beijing Syntech Laser Co., Ltd is recalling seven Nice Station Light Based Platform surgical lasers because the required laser safety certification label was not affixed to the product.

    Product
    Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1599-2018·2018-05-09

    Stryker 6381 M-1 Cot Fastener Recalled for Missing Manual Warnings

    Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.

    Product
    6381 M-1 Cot Fastener, catalog no. 6381000000
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1615-2018·2018-05-09

    IntroMedic Recalls Miriam Capsule Endoscope System Due to Battery Indicator Error

    IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System because the battery indicator may incorrectly display orange when the battery is fully charged.

    Product
    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1544-2018·2018-05-09

    BD MAX DNA MMK Recalled for Incorrect Package Insert Volume Instructions

    Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.

    Product
    BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
    Category
    Medical Device
    Distribution
    8 states