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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9201–9225 of 40095

  • HighFDA (Devices)·Z-2558-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for measurement inaccuracy

    Landauer is recalling QC nanoDot radiation dosimeters worldwide due to potential inaccuracy in radiation dose measurements. Some units may read outside the specified ±5.5% accuracy range.

    Product
    QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2547-2023·2023-09-20

    Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall

    Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2550-2023·2023-09-20

    Landauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy

    Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.

    Product
    Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2559-2023·2023-09-20

    Radiation monitoring dosimeters recalled for potential measurement inaccuracy

    Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters because they may give inaccurate readings. Some units may read outside the acceptable accuracy range.

    Product
    Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2534-2023·2023-09-20

    Procedural kits with ultrasonic transmission gel recalled for mislabeling

    Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2540-2023·2023-09-20

    Landauer nanoDot radiation dosimeters recalled for measurement accuracy defect

    Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.

    Product
    nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2582-2023·2023-09-20

    ACUSON Redwood 2.0 Ultrasound Systems Display Incorrect Measurement Results

    ACUSON Redwood 2.0 ultrasound systems may display underestimated measurement results when using an 18L6 transducer in Dual format, potentially leading to patient misdiagnosis. 796 units are affected worldwide.

    Product
    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2023·2023-09-20

    Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications

    Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.

    Product
    nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2572-2023·2023-09-20

    Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy

    Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.

    Product
    Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2570-2023·2023-09-20

    Radiation monitoring dosimeters recalled for potential measurement inaccuracy

    Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.

    Product
    Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2573-2023·2023-09-20

    Landauer NanoDots radiation dosimeters recalled for potential accuracy defect

    Landauer is recalling NanoDots radiation monitoring dosimeters worldwide due to potential accuracy defects. Some units may fall outside the specified +/-5.5% accuracy range.

    Product
    NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2539-2023·2023-09-20

    Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance

    Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.

    Product
    nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2588-2023·2023-09-20

    FILMARRAY GI Panel Software Recalled for False Positive Cryptosporidium Results

    BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.

    Product
    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2545-2023·2023-09-20

    Radiation Dosimeter Recall: nanoDot D2DXN Units May Have Inaccurate Readings

    Landauer is recalling nanoDot D2DXN radiation dosimeters worldwide due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.

    Product
    nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2577-2023·2023-09-20

    BeamAdjust software generates incorrect calibration files for radiation detectors

    BeamAdjust software Version 2.3.3 generates incorrect calibration files when using TIFF or DICOM image reference data, affecting radiation measurement accuracy in OCTAVIUS Detector systems.

    Product
    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2023·2023-09-20

    Landauer nanoDot dosimeters recalled for potential accuracy deviation

    Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.

    Product
    Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2574-2023·2023-09-20

    NanoDots radiation dosimeter recalled for potential measurement accuracy issues

    Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.

    Product
    NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2537-2023·2023-09-20

    Ultrasound gel procedural kits recalled for mislabeled use instructions

    Advance Medical Designs is recalling 1880 ultrasound gel procedural kits due to mislabeling that indicates inappropriate use. The affected kits were distributed in the US, Canada, UK, Panama, and the Netherlands.

    Product
    procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2560-2023·2023-09-20

    Landauer nanoDot radiation dosimeter may report inaccurate dose readings

    Landauer is recalling certain nanoDot radiation dosimeters worldwide due to a potential flaw in the optical stimulated luminescence material. Affected devices may provide inaccurate radiation dose readings.

    Product
    QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2553-2023·2023-09-20

    Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift

    Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.

    Product
    nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2587-2023·2023-09-20

    Philips X-Ray Systems Recalled for Foot Switch Malfunction Risk

    Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.

    Product
    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2023·2023-09-20

    Ultrasound gel recalled for mislabeling with inappropriate use instructions

    Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.

    Product
    50-GEL20; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2532-2023·2023-09-20

    ASG-001 ultrasound gel recalled for mislabeling regarding use instructions

    Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.

    Product
    ASG-001; Ultrasound gel
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2536-2023·2023-09-20

    Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling

    Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2562-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect

    Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.

    Product
    nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states