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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6826–6850 of 27393

  • HighFDA (Devices)·Z-0239-2024·2023-11-15

    Disposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label

    Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2024·2023-11-15

    BD Alaris Syringe Module includes non-validated compatible syringes in labeling

    CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.

    Product
    BD Alaris Syringe Module, REF 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2024·2023-11-15

    Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2024·2023-11-15

    IV Fitting Components Recalled Due to Manufacturing Defect and Leakage Risk

    B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing bloodstream infection risk.

    Product
    BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2024·2023-11-15

    Family Dollar Pregnancy Test Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0290-2024·2023-11-15

    Medical device blood oxygenation system recalled due to defective weld

    Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.

    Product
    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2024·2023-11-15

    Stryker Portal Entry Kit Recalled Due to Expired Product Distribution

    Stryker Corporation recalled 19 Portal Entry Kits distributed to surgical facilities in multiple U.S. states due to expired product. The kits aid surgeons in establishing arthroscopic portals.

    Product
    Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2024·2023-11-15

    Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

    Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

    Product
    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2024·2023-11-15

    ProxiDiagnost N90 X-ray Systems Recalled for Potential Ceiling Mount Failure

    Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.

    Product
    ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2024·2023-11-15

    DigitalDiagnost C90 radiographic system poses ceiling-mount failure risk

    Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.

    Product
    DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • 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-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-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-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-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-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-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-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-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-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-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-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