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 13683

HighFDA (Devices)·Z-2565-2023·2023-09-20
Landauer nanoDot radiation dosimeter units recalled due to accuracy failure
Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 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-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-2531-2023·2023-09-20
Remel Todd Hewitt Broth Culture Medium May Fail to Detect Target Organism
One lot of Remel Todd Hewitt Broth culture medium may fail to recover Group B Streptococci during testing or use with patient samples, potentially resulting in missed diagnoses.
Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Category
Medical Device
Distribution
Distributed nationwide
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-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-2546-2023·2023-09-20
Medical Device: Radiation Dosimeter Units May Have Inaccurate Readings
Landauer nanoDot D2DXN radiation dosimeters may measure outside the specified +/-5.5% accuracy range due to a potential non-conformance in the optical stimulated luminescence material. Approximately 13,950 units were distributed worldwide.
Product
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2556-2023·2023-09-20
Radiation Monitoring Dosimeter Accuracy Issue Affects nanoDot Devices
Landauer recalled nanoDot C radiation dosimeters due to potential accuracy errors in the optical stimulated luminescence material. Affected units may provide dosimetry readings outside the specified tolerance range of +/-5.5%.
Product
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; 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-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-2538-2023·2023-09-20
Radiation monitoring dosimeter units recalled for potential accuracy defect
Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-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-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-2524-2023·2023-09-20
Medtronic Bone Graft Recalled Due to Incorrect Size Labeling
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
Product
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Category
Medical Device
Distribution
Distributed nationwide
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-2555-2023·2023-09-20
Landauer nanoDot B Radiation Dosimeters Recalled for Measurement Accuracy
Landauer nanoDot B radiation dosimeters may have measurement inaccuracies outside the specified +/-5.5% range, potentially compromising radiation exposure monitoring. 16,820 units worldwide are affected.
Product
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; 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-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-2568-2023·2023-09-20
Radiation monitoring dosimeter accuracy issue prompts FDA Class II recall
Landauer is recalling 427 nanoDot radiation monitoring dosimeters that may provide inaccurate radiation exposure readings. Some units may fall outside the specified ±5.5% accuracy range due to a manufacturing issue.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-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-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-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-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-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-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

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8351–8375 of 13683