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.

Filters

Agency

Category

Minimum severity

Clear filters

3401–3425 of 39824

  • SevereFDA (Devices)·Z-2186-2025·2025-08-13

    BritePro Solo mini laryngoscope handles may not illuminate as intended

    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2185-2025·2025-08-13

    BritePro Solo stubby laryngoscope handles may not illuminate as intended

    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.

    Product
    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2187-2025·2025-08-13

    BritePro Solo fiber optic laryngoscope handles may not illuminate properly

    BritePro Solo Single-Use Fiber Optic Laryngoscope Handles, REFs 040-310AU and 040-310U, are being recalled because the handles may not illuminate as intended.

    Product
    BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2176-2025·2025-08-13

    Microbore extension sets are labeled as having an air eliminating filter

    Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.

    Product
    Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2180-2025·2025-08-13

    BD Alaris pump infusion sets may perform outside established flow ranges

    BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2179-2025·2025-08-13

    BD Alaris pump modules may perform outside established flow rate ranges

    BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.

    Product
    BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2025·2025-08-13

    Pinnacle 3 radiation planning software may miscalculate stopping power ratio

    Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.

    Product
    Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2025·2025-08-13

    Size 2 Guedel airways may carry small burrs that could detach

    One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.

    Product
    One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2264-2025·2025-08-13

    UIBC assay does not meet its labeled hemoglobin interference claim

    The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.

    Product
    UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2277-2025·2025-08-13

    Stryker SmartPump tourniquet cuff flanges may detach from the bladder

    Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.

    Product
    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2025·2025-08-13

    DASH COVID and flu tests may give a false negative result

    DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.

    Product
    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2276-2025·2025-08-13

    Guedel airways may carry small burrs that could detach and be inhaled

    One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.

    Product
    One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2272-2025·2025-08-13

    epoc BUN test cards may show a negative sodium bias

    epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.

    Product
    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2271-2025·2025-08-13

    DxI 600 with Spot B analyzer motor current resets below requirement

    DxI 600 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 177 systems are affected.

    Product
    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2265-2025·2025-08-13

    T4 Total ELISA kit box expiry exceeds the standards' shelf life

    T4 Total ELISA kits are being recalled because the expiration date on the kit box label and Certificate of Analysis exceeded the shelf life of the standards and control solutions by two months. 47 units affected.

    Product
    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2240-2025·2025-08-13

    Laparoscopic trays contain an inadvertently resterilized visualization system

    Laparoscopic Tray medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 40 units are affected.

    Product
    LAPAROSCOPIC TRAY. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2254-2025·2025-08-13

    Laparoscopic GYN kits contain an inadvertently resterilized visualization system

    Laparoscopic GYN medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 18 units are affected.

    Product
    LAPAROSCOPIC GYN. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2253-2025·2025-08-13

    Lap chole packs contain an inadvertently resterilized visualization system

    Lap Chole Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 85 units are affected.

    Product
    LAP CHOLE PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2258-2025·2025-08-13

    Major thoracoscopy basins contain an inadvertently resterilized visualization system

    Major Thoracoscopy Basin medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 128 units are affected.

    Product
    MAJOR THORACOSCOPY BASIN. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2244-2025·2025-08-13

    daVinci TruCustom bundles contain an inadvertently resterilized visualization system

    DAVINCI TRUCUSTOM BUNDLE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 626 units are affected.

    Product
    DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2259-2025·2025-08-13

    General robotic packs contain an inadvertently resterilized visualization system

    PACK GENERAL ROBOTIC medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 656 units are affected.

    Product
    PACK GENERAL ROBOTIC. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2238-2025·2025-08-13

    BD Trucount control kits carry incorrect standard deviation values for beads

    BD Trucount Controls 30 Test kits are being recalled because they contain incorrect standard deviation values for the low and high control beads, which compromises accurate bead count calculation. 629 kits affected.

    Product
    BD Trucount Controls, 30 Test - REF: 340335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2269-2025·2025-08-13

    UniCel DxI 600 analyzer motor current resets below the required setting

    UniCel DxI 600 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 271 systems are affected.

    Product
    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
    Category
    Medical Device
    Distribution
    Distributed nationwide