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.

44876–44900 of 50512

  • HighFDA (Devices)·Z-2451-2012·2012-10-03

    Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure

    Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2466-2012·2012-10-03

    KCI Recalls BariAir Therapy System Hand Pendent Due to Positioning Risk

    KCI USA, Inc. is recalling 575 BariAir Therapy System Hand Pendants because patients may inadvertently place the bed into a pseudo-exit position, posing a safety risk.

    Product
    BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2012·2012-10-03

    DEXIS Imaging Suite Software Recall for Patient Data Mixing

    Imaging Sciences International is recalling DEXIS Imaging Suite software versions 10.0.0 through 10.0.3 due to a defect that can mix patient records during database renumbering.

    Product
    DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2469-2012·2012-10-03

    ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets

    ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.

    Product
    Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2412-2012·2012-10-03

    McClure's Cherry Pie Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling 27 cherry pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Cherry Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2461-2012·2012-10-03

    Invacare Recalls I-Fit Shower Chairs Due to Quality and Adverse Event Data

    Invacare is voluntarily recalling 21,168 I-Fit Shower Chairs (Models 9780, 9781, 9781-1) based on returned units and adverse event reports.

    Product
    Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2407-2012·2012-10-03

    McClure's Orange Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Orange Cake because the ingredient list says 'flour' without specifying wheat, posing a risk to consumers with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Orange Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2449-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Module Recalled for Display Malfunction

    Terumo is recalling 72 Flow Modules for the Advanced Perfusion System 1 because they may fail to display blood flow information or illuminate the LED indicator.

    Product
    Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2376-2012·2012-10-03

    Triton Seafood Recalls Neptune Conch Fritters Due to Missing Wheat Allergen Labeling

    Triton Seafood Co. is recalling Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen wheat was not identified on the product label.

    Product
    Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2421-2012·2012-10-03

    McClure's Shoo Fly Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Shoo Fly Pies because the ingredient list says 'flour' but does not specify wheat, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Shoo Fly Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2413-2012·2012-10-03

    McClure's Apple Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling 40 apple pies because the ingredient list says 'flour' without specifying wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Apple Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2417-2012·2012-10-03

    McClure's Coconut Custard Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Coconut Custard Pies because the ingredient list says 'flour' but does not specify wheat, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Coconut Custard Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2400-2012·2012-10-03

    McClure's German Chocolate Cake Recalled for Undeclared Wheat Allergen

    McClure's German Chocolate Cake is being recalled because the ingredient list says 'flour' without specifying wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. German Chocolate Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2372-2012·2012-10-03

    Meijer Walnuts Recalled Due to Unlabeled Pecans

    Meijer Distribution is recalling 16-ounce bags of walnuts because some contain unlabeled pecans, a potential allergen.

    Product
    Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2470-2012·2012-10-03

    Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit

    Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.

    Product
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2401-2012·2012-10-03

    McClure's Chocolate Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling 96 chocolate cakes because the ingredient list says 'flour' without specifying wheat, a major allergen.

    Product
    McClure's Pies & Salads, Inc. Chocolate Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2410-2012·2012-10-03

    McClure's Peach Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads is recalling Peach Pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Peach Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2377-2012·2012-10-03

    Triton Seafood Recalls Neptune Conch Fritters for Missing Wheat Allergen

    Triton Seafood Co. is recalling Neptune brand frozen conch fritters and batter because the label failed to identify wheat as an ingredient.

    Product
    Approximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2374-2012·2012-10-03

    Haldeman Mills Recalls Yellow Corn Meal Due to Fumonisin Contamination

    Haldeman Mills is recalling specific 25 lb and 50 lb bags of Bulk Foods Yellow Corn Meal because FDA samples tested positive for Fumonisin.

    Product
    Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2415-2012·2012-10-03

    McClure's Banana Cream Pie Recalled for Undeclared Wheat Allergen

    McClure's Banana Cream Pie is being recalled because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Banana Cream Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2419-2012·2012-10-03

    McClure's Chocolate Cream Pie Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling 20 chocolate cream pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Chocolate Cream Pie
    Category
    Food
    Distribution
    4 states