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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6251–6275 of 13666

  • HighFDA (Devices)·Z-1998-2024·2024-06-12

    Vascular graft recall due to slider mechanism separation defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft function.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1942-2024·2024-06-12

    WAVi Research EEG Desktop System recalled due to FDA Warning Letter

    WAVi Co. is recalling 281 units of the WAVi Research EEG Desktop System following an FDA-issued Warning Letter. The company requested the return of components due to closure of their research study.

    Product
    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System a
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1982-2024·2024-06-12

    Vascular Graft Component Separation Risk in ADVANTA VXT Grafts

    ADVANTA VXT vascular grafts are being recalled due to reported separation of the Slider GDS Swivel Rod from its core. This mechanical failure could compromise graft function.

    Product
    ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2024·2024-06-12

    Vascular Graft Recalled Due to Swivel Rod Separation Risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.

    Product
    ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2024·2024-06-12

    Vascular graft recalled for slider rod component separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2024·2024-06-12

    FLIXENE Vascular Graft Recall Due to Swivel Rod Component Separation

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.

    Product
    FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2024·2024-06-12

    Vascular graft slider component separation poses implant failure risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.

    Product
    ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2024·2024-06-12

    Vascular Graft Recall Due to Swivel Rod Separation

    Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1964-2024·2024-06-12

    Vascular Graft Component Separation Recall from Atrium Medical

    Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation from the Swivel Core. Component separation could compromise device function.

    Product
    ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2024·2024-06-12

    FLIXENE Vascular Graft Recall for Swivel Rod Component Separation

    Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.

    Product
    FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Rod Separation Recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core, with a gap between components. Approximately 53,308 units are affected globally.

    Product
    ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2024·2024-06-12

    BD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results

    Becton Dickinson is recalling 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems because they may produce false negative results due to decreased enzyme activity. The kits were distributed nationwide and internationally.

    Product
    BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2024·2024-06-12

    Atrium Medical Vascular Graft Swivel Component Separation Recall

    Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.

    Product
    ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2024·2024-06-12

    Surgical imaging device electrical component may intermittently shut off

    The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.

    Product
    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1947-2024·2024-06-12

    Leica HistoCore PEGASUS tissue processor recalled for tissue damage

    LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.

    Product
    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2024·2024-06-12

    Quality Control Tool Vitamin B12 Range Verifier Recalled by FDA

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2024·2024-06-05

    Medline Sub-G Endotracheal Tubes with Subglottic Suctioning—Inflation and Suction Defects

    Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.

    Product
    Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2024·2024-06-05

    Surgical screwdrivers recalled for failure to engage with implant screws

    Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.

    Product
    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2024·2024-06-05

    Neurovascular devices recalled due to inadequate endotoxin testing

    Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.

    Product
    DAC 044 115cm, Catalog: 90760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1900-2024·2024-06-05

    EsophaCap Sponge May Detach From String During Removal

    Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2024·2024-06-05

    Dako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage

    Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.

    Product
    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2024·2024-06-05

    Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.

    Product
    ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide