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.

14076–14100 of 22168

  • HighCPSC·23293·2023-09-21

    H&M Men's Clasp Beaded Bracelets Recalled for High Lead Content

    H&M is recalling about 12,290 men's clasp beaded bracelets because the clasp contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    Men's clasp beaded bracelets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-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-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-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-1512-2023·2023-09-20

    US Foods Peanut Butter Toffee Bar recalled for possible plastic contamination

    Killer Brownie Ltd is recalling US Foods Peanut Butter Toffee Bars (3.4oz) distributed in Illinois due to possible plastic foreign material. Consumers should not eat affected units.

    Product
    US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
    Category
    Food
    Distribution
    1 state
  • 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-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-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
  • 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-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 (Food)·F-1516-2023·2023-09-20

    Knorr Alphabet Pasta Soup Recalled for Undeclared Egg Allergen

    Knorr Letras con Tomate soup mix is being recalled because it contains undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Knorr Letras con Tomate Tomato Based Alphabet Pasta Soup Mix 3.5 oz UPC: 048001716186
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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 (Drugs)·D-1149-2023·2023-09-20

    Prescription Drug Sucralfate Suspension Recalled for Out-of-Specification Potency

    VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.

    Product
    SUCRALFATE — SUCRALFATE (SUCRALFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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