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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6851–6875 of 27364

  • HighFDA (Devices)·Z-0255-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recall for Incorrect Expiration Date Labeling

    Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2024·2023-11-15

    Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers

    Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.

    Product
    Veradius Unity Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0134-2024·2023-11-15

    Allergan Universal Fill Kit for tissue expanders recalled due to leakage risk

    B. Braun Medical is recalling Allergan Universal Fill Kits for tissue expanders due to a manufacturing defect that may cause device leakage. Leakage can delay treatment, increase infection risk, and potentially create life-threatening situations.

    Product
    ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2024·2023-11-08

    Stolen McGRATH MAC Video Laryngoscopes Recalled for Failed Quality Tests

    Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.

    Product
    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0170-2024·2023-11-08

    Senhance Robotic Surgical System uncontrolled arm motion malfunction

    Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.

    Product
    Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0195-2024·2023-11-08

    Siemens Cios Alpha X-ray system software defect may cause patient misdiagnosis

    Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.

    Product
    Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2024·2023-11-08

    Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis

    Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.

    Product
    ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2024·2023-11-08

    RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction

    Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.

    Product
    RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2024·2023-11-08

    RX Daytona Plus clinical chemistry analyzer may report incorrect test results

    The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.

    Product
    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2024·2023-11-08

    Oncology Information System Document Values Not Visible in Read-Only Mode

    RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.

    Product
    RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0215-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.

    Product
    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2024·2023-11-08

    AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging

    MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.

    Product
    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2024·2023-11-08

    RX Modena Clinical Chemistry Analyzer Recalled for Incorrect Rerun Results

    Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.

    Product
    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2024·2023-11-08

    Unity Total Knee System Inserts May Be Mislabeled With Wrong Size

    Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.

    Product
    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0168-2024·2023-11-08

    McGrath Mac 2 Laryngoscope Blade Recalled for Anti-Fog Agent Defect

    Covidien is recalling McGrath Mac 2 disposable laryngoscope blades due to defective anti-fog coating that can cause condensation and vision obstruction. Approximately 42,367 units were distributed across the United States and internationally.

    Product
    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0169-2024·2023-11-08

    McGrath Mac 2 Disposable Laryngoscope Blades Recalled for Ineffective Anti-Fog Coating

    Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.

    Product
    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0207-2024·2023-11-08

    Blood Gas Analyzer Software Issue Causes Erroneous Creatinine Results During Startup

    Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.

    Product
    Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2024·2023-11-08

    RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly

    RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.

    Product
    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2024·2023-11-08

    Orthopedic knee implant components mislabeled; size mix-up risk

    Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.

    Product
    Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0208-2024·2023-11-08

    POC Analyzer Risk of Erroneous Creatinine Results During Cartridge Startup

    Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.

    Product
    Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2024·2023-11-08

    Cosmedent FlexiCup Polishing System Recalled for Crumbling Elastomer Cup

    Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.

    Product
    Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2024·2023-11-08

    Coapt Dome Electrode Gen2 System Recalled for Burn Risk

    Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.

    Product
    Coapt Dome Electrode, Gen2 system, cutaneous electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.

    Product
    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0149-2024·2023-11-01

    Monoject 35 mL Syringe Recalled for Pump Incompatibility Issues

    Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.

    Product
    Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide