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.

28576–28600 of 50488

  • HighFDA (Food)·F-1532-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of Red Pepper Seasoning because milk is not listed in the ingredient or allergen statements.

    Product
    Pocahontas - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1535-2018·2018-06-13

    Ahold USA Recalls Stop and Shop Broccoli Cuts Due to Listeria

    Ahold USA is recalling Stop and Shop Broccoli Cuts after a Connecticut report found Listeria monocytogenes in the product.

    Product
    Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ; Distributed by Foodhold USA, LLC, Landover, MD 20785; UPC: 688267009266, BEST BY 03/15/2020
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    Product
    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2018·2018-06-13

    Tosoh ST-AIA PACK CK-MB Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK CK-MB assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2018·2018-06-13

    GE Healthcare Recalls Centricity Universal Viewer for Missing Image Series

    GE Healthcare is recalling 252 units of the Centricity Universal Viewer because image series may be missing from exams without a user warning.

    Product
    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2018·2018-06-13

    Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2018·2018-06-13

    Tosoh AIA-PACK TSH 3rd Generation Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1533-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of red pepper seasoning because milk is not listed in the ingredient statement.

    Product
    Premium - Recipe Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2133-2018·2018-06-13

    Orthofix Recalls TN Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the plates during surgery.

    Product
    TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2018·2018-06-13

    Santajoy Laser Projectors Recalled for Exceeding Federal Radiation Standards

    Santajoy Ornament & Giftware Co. is recalling E-Z Illuminations laser projectors because they may emit radiation exceeding federal standards for Class IIIa products.

    Product
    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2018·2018-06-13

    Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1531-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of Red Pepper Seasoning because milk is not listed in the ingredient or allergen statements.

    Product
    Blue Mountain Valley - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2066-2018·2018-06-13

    Tosoh ST-AIA PACK CEA Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK CEA assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2018·2018-06-13

    Becton Dickinson Recalls BD Vacutainer Plus SST Tubes Due to Stopper Defect

    Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tubes.

    Product
    BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1540-2018·2018-06-13

    Heritage Shortbread Lemon Infused Recalled for Missing Wheat Labeling

    Heritage Shortbread is recalling Lemon Infused shortbread because the label failed to list wheat as an ingredient.

    Product
    Heritage Shortbreaad Lemon Infused Ingredients: Enriched flour, pasteurized cream(milk),sugar, salt, pure crystallized ginger, organic ground ginger Mfg. by Heritage Shortbread, Inc. Hilton Head Island, SC 09926
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2086-2018·2018-06-13

    Tosoh FSH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK TT3 thyroid assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2018·2018-06-13

    BD Vacutainer Plus SST Tubes Recalled for Stopper Defect

    Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tube.

    Product
    BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2018·2018-06-13

    Orthofix Recalls TL-HEX TruLok Hexapod System Due to Incompatibility

    Orthofix Srl is recalling 408 units of TL-HEX TruLok Hexapod System double row footplates because they are incompatible with current struts, posing a risk of dimensional interference.

    Product
    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system.…
    Category
    Medical Device
    Distribution
    1 state