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.

28601–28625 of 50488

  • HighFDA (Drugs)·D-0841-2018·2018-06-13

    Apotex Recalls Fluticasone Propionate Nasal Spray Due to Glass Particles

    Apotex Inc. is recalling Fluticasone Propionate Nasal Spray because glass particles were found in the product. Consumers should stop using the affected lot.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2018·2018-06-13

    Tosoh ST-AIA PACK hsE2 Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK hsE2 assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2018·2018-06-13

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

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

    Product
    ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2018·2018-06-13

    Tosoh Estradiol Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2018·2018-06-13

    Orthofix Rival Reduce Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix is voluntarily recalling Rival Reduce Kit locking screws because they failed to properly engage plates during surgery.

    Product
    Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2120-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.

    Product
    Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2069-2018·2018-06-13

    Tosoh ST-AIA CA 19-9 Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK CA 19-9 assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2018·2018-06-13

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

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

    Product
    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2018·2018-06-13

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

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

    Product
    ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2018·2018-06-13

    Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference

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

    Product
    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2018·2018-06-13

    Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa can cause inaccurate test results.

    Product
    ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1530-2018·2018-06-13

    Sauer Red Pepper Seasoning Recalled 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
    Sauer - 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-1545-2018·2018-06-13

    Dean Foods Recalls Baskin Robbins Mint Chocolate Chip Ice Cream

    Dean Foods is recalling Baskin Robbins Mint Chocolate Chip ice cream because it may contain unlabeled coconut, a major food allergen.

    Product
    Baskin Robbins Mint Chocolate Chip
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2018·2018-06-13

    Orthofix Rival View Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.

    Product
    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2111-2018·2018-06-13

    CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing

    CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.

    Product
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1534-2018·2018-06-13

    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
    Code - 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-2124-2018·2018-06-13

    Orthofix Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2123-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific Non-Locking Screws because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2073-2018·2018-06-13

    Tosoh ST-AIA PACK cTnI 2nd Gen Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK cTnI 2nd Gen assays because the drug Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2018·2018-06-13

    Orthofix Rival Plating System Recalled Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System because locking screws failed to properly engage plates during surgery.

    Product
    Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2101-2018·2018-06-13

    GE Healthcare Recalls Centricity PACS-IW Medical Image Viewer

    GE Healthcare is recalling 44 units of the Centricity PACS-IW with Universal Viewer because image series may be missing without warning.

    Product
    Centricity PACS-IW with 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2018·2018-06-13

    Tosoh Prolactin Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates during surgery.

    Product
    H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

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

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

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

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

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide