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.

33726–33750 of 50502

  • HighFDA (Food)·F-0533-2017·2016-12-07

    Benson's Old Home Kitchens Lemon Creme Cake Recalled for Undeclared Peanut

    Benson's Old Home Kitchens is recalling specific Lemon Creme Cake products because they contain undeclared peanut protein, a major food allergen.

    Product
    Old Home Kitchens, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 32 oz. Sliced Lemon Creme Cake, and Winn Dixie, 32 oz. Lemon Creme Cake
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0539-2017·2016-12-07

    Benson's Dutch Apple Creme Cake Recalled for Undeclared Peanut

    Benson's Old Home Kitchens is recalling 28-ounce Dutch Apple Creme Cakes because they contain undeclared peanut protein. The product was distributed in nine states.

    Product
    No Label Dutch Apple Creme Cake, 28 oz.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0542-2017·2016-12-07

    Mel-O Cream Donuts Recalls Star Shaped Shells Due to Foreign Object

    Mel-O Cream Donuts International, Inc. is recalling specific batches of Star Shaped Shells because a human fingertip was found in the product filling line.

    Product
    Star Shaped Shells; Best If Used By 02/26/2017; Batch 162734736; NET WT 11.46 Pounds; Approximate Unit Count [Per Case]: 9 Dozen [108 units]
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0559-2017·2016-12-07

    Purely Elizabeth Chocolate Sea Salt Probiotic Granola Recalled for Undeclared Soy

    Purely Elizabeth is recalling Chocolate Sea Salt Probiotic Granola due to undeclared soy lecithin, posing a risk to individuals with soy allergies.

    Product
    Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0535-2017·2016-12-07

    Winn Dixie Cream Cheese Creme Cake Recalled for Undeclared Peanut

    Benson's Old Home Kitchens is recalling Winn Dixie Cream Cheese Creme Cake because it contains undeclared peanut protein, a major allergen.

    Product
    Winn Dixie 32 oz. Cream Cheese Creme Cake
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0684-2017·2016-12-07

    MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.

    Product
    Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2017·2016-12-07

    Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results

    Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.

    Product
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2017·2016-12-07

    Hamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk

    Hamilton Medical is recalling 44 MR1 ventilators because the oxygen tubing and connector could become loose during preparation, potentially compromising ventilation support.

    Product
    Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays

    Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2017·2016-12-07

    Par Pharmaceutical Recalls Travoprost Ophthalmic Solution Due to Sterility Concerns

    Par Pharmaceutical is recalling specific lots of Travoprost Ophthalmic Solution because the dropper tips may be damaged, compromising sterility.

    Product
    Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2017·2016-12-07

    Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes

    Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0543-2017·2016-12-07

    Mel-O-Cream and Hy-Vee Jumbo Ring Donuts Recalled for Foreign Object

    Mel-O Cream Donuts International is recalling Jumbo Ring Donuts because a human fingertip was found in the product filling line.

    Product
    Jumbo Ring Donut; Best If Used By 02/26/2017; Approximate Unit Count: 84 Units; Brands: Mel-O-Cream and Hy-Vee
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0690-2017·2016-12-07

    Domain Surgical Recalls FMsealer Open Shears Due to Jaw Fractures

    Domain Surgical is recalling FMsealer Open Shears (Model FM3001) because fixed jaw fractures were observed during clinical usage.

    Product
    FMsealer Open Shears. Model FM3001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0544-2017·2016-12-07

    Mel-O Cream Donuts Recalls Jumbo Apple Fritters Due to Foreign Object

    Mel-O Cream Donuts International is recalling Jumbo Apple Fritters because a human fingertip was found in the product filling line.

    Product
    Jumbo Apple Fritter; Approximate Unit Count: 6 Dozen; Mel-O-Cream Donuts Intl. Inc. Springfield, IL 62711
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·16V880000·2016-12-07

    Daimler Recalls 2008-2009 Sterling Bullet Trucks Due to Fire Risk

    Daimler Trucks is recalling 2008-2009 Sterling Bullet 4500 and 5500 cab chassis vehicles because a short circuit in the alternator may increase the risk of a fire.

    Product
    STERLING — STERLING BULLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2017·2016-12-07

    MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve Cups because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2017·2016-12-07

    MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

    Product
    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2017·2016-12-07

    Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns

    Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2017·2016-12-07

    Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns

    Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.

    Product
    OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0536-2017·2016-12-07

    Benson's Old Home Kitchens Recalls Vanilla Cream Cakes for Undeclared Peanut

    Benson's Old Home Kitchens is recalling specific Winn Dixie and Old Home Kitchens vanilla cream cakes because they contain undeclared peanut protein.

    Product
    Winn Dixie 14 oz. Sliced Vanilla Cream Cake, Winn Dixie 32 oz. Vanilla Creme Cake, Old Home Kitchens, 14 oz. Sliced Vanilla Cream Cake
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0687-2017·2016-12-07

    MicroPort Recalls Conserve Hip Shells Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve hip shells because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide