The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

16726–16750 of 88183

  • 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 (Food)·F-1508-2023·2023-09-20

    Trader Joe's Almond Windmill Cookies Recall: Rocks Found in Product

    Fantasy Cookie Corporation is recalling Trader Joe's Almond Windmill Cookies because rocks were found in the product. Consumers should not eat affected cookies.

    Product
    Trader Joe's Almond Windmill Cookies Buttery, tender cookies topped with crunchy almonds. Net Wt. 15 oz.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2549-2023·2023-09-20

    Radiation Dosimeter Recall for Potential Measurement Accuracy Issues

    Landauer recalls Calibrate nanoDot radiation dosimeters (Model 03064-OTO) worldwide due to potential inaccuracies. Some units may exceed the ±5.5% accuracy specification, resulting in inaccurate radiation exposure readings.

    Product
    Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; 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…
    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 (Food)·F-1514-2023·2023-09-20

    Knorr Pasta Soup Mix recalled for undeclared egg allergen

    Conopco (Unilever) recalled Knorr Estrellitas con Tomate soup mix nationwide due to undeclared egg allergen. No illnesses have been reported.

    Product
    Knorr Estrellitas con Tomate Tomato Based Star Pasta Soup Mix 3.5 oz UPC: 048001716193
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-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-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 (Food)·F-1505-2023·2023-09-20

    Twin City Foods Frozen Corn Recalled for Listeria Contamination Risk

    Multiple frozen corn products distributed nationwide are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.

    Product
    Kernel Corn, BEST PRICE TOPVALU, net wt. per bag 300g. Label is in foreign language. UPC 4549414086232 Signature Select Golden Corn Super Sweet, Product of USA, net wt. per bag 12oz, 12 bags per case. UPC 21130090655 Food Lion Super Sweet Cut Yellow Corn, Product of USA, net…
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1502-2023·2023-09-20

    Sodium Nitrite Food Additive Recalled Due to Metal Fragment Contamination

    Chemtrade Solutions is recalling food-grade Sodium Nitrite due to possible metal fragment contamination. The product may contain ferrous metal particles 1 mm or smaller.

    Product
    Sodium Nitrite, Granular Super Free-Flowing Food Grade, 50lb polyethylene and paper bags - 50 per pallet
    Category
    Food
    Distribution
    5 states
  • 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-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 (Food)·F-1515-2023·2023-09-20

    Knorr Soup Mix Recalled for Undeclared Egg Allergen

    Conopco is recalling Knorr Fideos con Tomate Tomato Based Pasta Soup Mix because it contains undeclared egg. The product was distributed nationwide with best-by dates through July 6, 2024.

    Product
    Knorr Fideos con Tomate Tomato Based Pasta Soup Mix 3.5 oz UPC: 048001716162
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1511-2023·2023-09-20

    Ritchie's Distribution Pizza Dough Recall Due to Undeclared Soy Allergen

    Cassanos Inc is recalling Ritchie's Distribution Pizza Dough (lots 193, 194) distributed in Ohio due to undeclared soy flour. Consumers with soy allergies should not consume this product.

    Product
    Ritchie's Distribution Pizza Dough on Parchment: packaged as 16in (regular)
    Category
    Food
    Distribution
    1 state
  • 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-2578-2023·2023-09-20

    Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification

    Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.

    Product
    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide