The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14101–14125 of 22168

  • HighFDA (Food)·F-1507-2023·2023-09-20

    Southern Belle Crabmeat Stuffing Recalled for Plastic Contamination

    Shaw's Southern Belle Frozen Foods recalled 600 pounds of Southern Belle Seafood Crabmeat Stuffing due to a plastic fragment found in the product. The affected lot is 042504 with a use-by date of 08/23/2023, distributed domestically.

    Product
    Southern Belle Seafood Crabmeat Stuffing, Packed: 2/25 lb. Bag, Net Weight: 50 lb. (22.68 kg), Use By: 08/23/2023
    Category
    Food
    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-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-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-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-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-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-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 (Food)·F-1503-2023·2023-09-20

    Twin City Foods Frozen Corn Recalled Nationwide for Listeria Risk

    Twin City Foods recalled frozen corn products due to potential Listeria monocytogenes contamination. Products distributed nationwide and internationally.

    Product
    Individually Quick Frozen (IQF) Corn distributed in BULK TOTES (1650lbs and 1750lbs) to consignees for further processing. Bulk tote labels have cooking instructions. Individually Quick Frozen (IQF) Super Sweet Corn, foodservice item, packaged in 32oz. plastic bag, 12 bags per
    Category
    Food
    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-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 (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 wt
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-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-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-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 (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 (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-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 (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 (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 N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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