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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

8351–8375 of 13652

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-2541-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.
Product
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2551-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2554-2023·2023-09-20
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2575-2023·2023-09-20
Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect
Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.
Product
Reader, nanoDot adapter, EU Model Number VINLADA003; 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-2557-2023·2023-09-20
Radiation Dosimeter May Provide Inaccurate Dose Measurements
Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2566-2023·2023-09-20
Landauer nanoDot radiation dosimeters potentially outside accuracy specifications
Landauer is recalling nanoDot radiation dosimeters due to a potential manufacturing defect in the optical measurement material. Some units may fall outside the specified ±5.5% accuracy range.
Product
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; 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-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-2542-2023·2023-09-20
Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
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-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-2544-2023·2023-09-20
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Product
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; 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-2548-2023·2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2567-2023·2023-09-20
Landauer nanoDot radiation dosimeters may be outside accuracy specifications
Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement material.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
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-2564-2023·2023-09-20
Radiation monitoring dosimeter recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot radiation monitoring dosimeters due to a potential defect in the optical luminescence material that may result in inaccurate radiation dose readings.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; 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-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-2552-2023·2023-09-20
Radiation dosimeter recalled for potential measurement accuracy deviations
Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2561-2023·2023-09-20
Radiation dosimeter may report inaccurate exposure readings
Landauer recalls nanoDot D2DNN radiation dosimeters worldwide due to potential accuracy degradation that may cause incorrect exposure readings.
Product
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-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-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

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