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.

34326–34350 of 50502

  • HighFDA (Devices)·Z-0245-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2017·2016-10-26

    Windstone Medical Head and Neck Surgical Kits Recalled for Sterility Risk

    Windstone Medical Packaging is recalling Head and Neck surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0121-2017·2016-10-26

    Kabobs Recalls Mac & Cheese Poppers Due to E. coli Contamination

    Kabobs Inc is recalling Mac & Cheese Poppers because they were made with flour contaminated with E. coli O121.

    Product
    MAC & CHEESE POPPERS, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0184-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits

    Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0225-2017·2016-10-26

    Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 20 liposuction kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0154-2017·2016-10-26

    Union Bagel Shop Recalls Italian Bagels for Undeclared Wheat

    Union Bagel Shop is recalling Italian bagels sold in Grande, Oregon, due to undeclared wheat. The voluntary recall was initiated by the firm.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Italian: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Marinara Sauce, Oregano.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0156-2017·2016-10-26

    Union Bagel Shop Recalls Sesame Seed Bagels Due to Undeclared Wheat

    Union Bagel Shop is recalling sesame seed bagels because the packaging fails to declare wheat as an ingredient. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Sesame Seed: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Sesame Seeds.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0175-2017·2016-10-26

    Gourmet Foods Recalls Shrimp Coconut Brochettes Due to E. coli Flour

    Gourmet Foods, Inc. is recalling Shrimp Coconut Brochettes because they were manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Shrimp Coconut Brochette Pack Size: 156 ea. per case UPC: 23811-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0295-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure

    Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.

    Product
    Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Drugs)·D-0112-2017·2016-10-26

    Supernus Recalls Trokendi XR Capsules Due to Assay Failure

    Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed to meet assay specifications.

    Product
    TROKENDI XR — TROKENDI XR (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2017·2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise

    ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.

    Product
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2017·2016-10-26

    Windstone Medical Recalls Morris Hysto Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 186 Morris Hysto Pack kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2017·2016-10-26

    Windstone Medical Knee Packs Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0136-2017·2016-10-26

    Kabobs Mini Deep Dish Mushroom Pizza Recalled for E. coli O121

    Kabobs Inc is recalling Mini Deep Dish Mushroom Pizza because it was made with flour contaminated with E. coli O121.

    Product
    MINI DEEP DISH MUSHROOM PIZZA, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0138-2017·2016-10-26

    Olympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions

    Olympus is recalling OER-Pro endoscope reprocessors because instructions may incorrectly suggest skipping precleaning steps. Users must conduct manual cleaning.

    Product
    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0087-2017·2016-10-26

    Zimmer Biomet Recalls Uniflex Humeral Nail Guide Pins Due to Packaging Error

    Zimmer Biomet is recalling 22 units of Uniflex Humeral Nail guide pins because they may be packaged with the wrong combination of pins, potentially causing surgical delays or injury.

    Product
    Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant…
    Category
    Medical Device
    Distribution
    6 states
  • HighCPSC·17021·2016-10-26

    H-E-B Recalls Brazos Embossed Star Chairs Due to Fall Hazard

    H-E-B is recalling Brazos Embossed Star Chairs because weld defects may cause armrests to detach, posing a fall hazard. No injuries have been reported.

    Product
    Brazos Embossed Star Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2017·2016-10-26

    X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.

    Product
    Calix P PEEK Lumbar System, PLIF Trial
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0156-2017·2016-10-26

    Windstone Medical Breast Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0142-2017·2016-10-26

    Kabobs Recalls Mini Vegetable Springrolls Due to E. coli O121 Contamination

    Kabobs Inc is recalling Mini Vegetable Springrolls because they were manufactured with flour contaminated with E. coli O121.

    Product
    MINI VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0160-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2017·2016-10-26

    Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up

    Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.

    Product
    CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide