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.

43476–43500 of 50511

  • HighFDA (Devices)·Z-1482-2013·2013-06-12

    SpineFrontier Recalls Straight Impactor Devices Due to Handle Plate Breakage

    SpineFrontier, Inc. is recalling 10 Straight Impactor - Dorado IBC devices because the impactor plate on the handle broke off during use.

    Product
    Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2013·2013-06-12

    Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach

    Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2013·2013-06-12

    Philips Recalls BrightView SPECT Gamma Cameras Due to Mechanical Failure

    Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.

    Product
    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed…
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-1471-2013·2013-06-12

    Hood Cottage Cheese with Chive Recalled for Possible Metal Fragments

    HP Hood LLC is recalling specific lots of Cottage Cheese with Chive due to the possible presence of metal fragments.

    Product
    Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4%…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1482-2013·2013-06-12

    Metabolic Whey Protein Recalled for Unlabeled Milk and Soy Allergens

    Chemi-Source Inc is recalling Metabolic Whey protein products because milk and soy allergens were not listed on the labels.

    Product
    Metabolic Whey - Straw/Banana¿5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1484-2013·2013-06-12

    It Works Ultimate Profit Chocolate Protein Powder Recalled for Milk Allergen Mislabeling

    Chemi-Source Inc is recalling It Works Ultimate Profit Chocolate protein powder because the whey ingredient was not listed as a milk allergen.

    Product
    It Works Ultimate Profit Chocolate¿1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1485-2013·2013-06-12

    It Works Ultimate Profit Vanilla Whey Protein Recalled for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling It Works Ultimate Profit Vanilla whey protein because the milk allergen was not listed on the label.

    Product
    It Works Ultimate Profit Vanilla¿1.55 LBS: Whey Protein Concentrate/ Isolate, Soy Protein, Soy Hull Flower Contains: Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2013·2013-06-12

    Berchtold Recalls Hand Controls for Operon Surgical Tables

    Berchtold Corp. is recalling 3,763 hand controls for Operon surgical tables due to reports of unintended movements.

    Product
    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1491-2013·2013-06-12

    Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2013·2013-06-12

    Shimadzu Mobile X-ray Systems Recalled for Loose Internal Screws

    Shimadzu Medical Systems is recalling 200 Mobile DaRt Evolution X-ray systems due to a potential risk of internal screws becoming loose.

    Product
    Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2013·2013-06-12

    Sprouts Farmers Market Whey Protein Vanilla Recalled for Undeclared Milk Allergen

    Sprouts Farmers Market Whey Protein Vanilla is being recalled because the whey ingredient is not listed as milk, a major allergen. Consumers with milk allergies are at risk of serious allergic reactions.

    Product
    Sprouts Farmers Market Whey Protein Vanilla: 1 lbs, 2 lbs : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68118-9 (1 lbs) UPC 6-46670 68124-0 (2 lbs)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2013·2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Kit Recalled

    I-Flow LLC is voluntarily removing 75 units of the ON-Q Pain Relief System T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

    Product
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2013·2013-06-12

    Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.

    Product
    Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2013·2013-06-12

    Stryker T5 Zipper Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1489-2013·2013-06-12

    Massive Muscle Gainer Recalled for Undeclared Milk Allergen

    Chemi-Source Inc is recalling Massive Muscle Gainer weight gainer because the whey and casein ingredients are not listed as milk, a major allergen.

    Product
    Massive Muscle Gainer- Weight Gainer¿ French Vanilla¿10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate UPC 6-09492 73003-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1492-2013·2013-06-12

    Chemi-Source Low Carb Protein Recalled for Undeclared Milk Allergen

    Chemi-Source Inc. is recalling Low Carb Protein Creamy Chocolate because the milk ingredient is not listed on the label, posing a risk to consumers with milk allergies.

    Product
    Low Carb Protein¿ -¿ Creamy Chocolate¿1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 72017-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1473-2013·2013-06-12

    HP Hood Recalls 1% Low Fat Cottage Cheese Due to Metal Fragments

    HP Hood LLC is recalling 1% Low Fat Cottage Cheese under multiple brands due to the possible presence of metal fragments.

    Product
    1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Low Fat Cottage Cheese, SMALL CURD…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1474-2013·2013-06-12

    Hill-Rom Recalls SlingBar 360 Patient Lifting Devices Due to Impalement Risk

    Hill-Rom is recalling 16 SlingBar 360 patient lifting devices because a retrospective review found a potential for impalement if a person falls onto the hooks.

    Product
    SlingBar 360. Designed to meet the needs for lifting humans.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1503-2013·2013-06-12

    Whey Protein Powder Recalled for Missing Milk Allergen Labeling

    Chemi-Source Inc. is recalling Delicious Whole-istic Whey Protein Duch Chocolate because the milk allergen was not listed on the label.

    Product
    Delicious Whole-istic Whey Protein Duch Chocolate 1.6 lbs: Whey Protein/Isolate, Contains: Dairy, Soy Lecithin UPC8-54809 0030-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2013·2013-06-12

    Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.

    Product
    Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1480-2013·2013-06-12

    Whey Protein Recall for Unlabeled Milk Allergen

    Chemi-Source Inc. is recalling Isolate Whey Protein French Vanilla because the milk allergen was not listed on the label.

    Product
    Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol UPC 6-09492 73011-4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2013·2013-06-12

    Metabolic Whey Protein Recalled for Undeclared Milk and Soy Allergens

    Chemi-Source Inc. is recalling Metabolic Whey protein products because milk and soy allergens were not properly labeled. Consumers with allergies to these ingredients should stop using the product.

    Product
    Metabolic Whey - Vanilla¿5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin UPC 6-09492 72051-1 (VANILLA) UPC 6-09492 72054-2 (FRENCH VANILLA)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1472-2013·2013-06-12

    HP Hood Recalls 4% Cottage Cheese Due to Possible Metal Fragments

    HP Hood LLC is recalling 4% cottage cheese under multiple brands due to the possible presence of metal fragments. The product was distributed in 21 states.

    Product
    4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (b) Weis brand SMALL CURD original cottage cheese…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1502-2013·2013-06-12

    Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns

    Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.

    Product
    Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide