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.

34276–34300 of 50502

  • HighNHTSA·16V781000·2016-10-26

    GM Recalls 2016 Chevrolet Malibu for Side Air Bag Defect

    General Motors is recalling 2016 Chevrolet Malibus because the side-impact air bag fabric may tear during deployment, potentially increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility in custom surgical kits.

    Product
    GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2017·2016-10-26

    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
    Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0140-2017·2016-10-26

    Kabobs Recalls Coconut Lobster Tail Due to E. coli O121 Contamination

    Kabobs Inc is recalling Coconut Lobster Tail because it was manufactured with flour contaminated with E. coli O121.

    Product
    COCONUT LOBSTER TAIL, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0232-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 175 Major Kits (PHC1307A) because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2017·2016-10-26

    Windstone Medical Recalls Total Hip Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 54 Total Hip Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2017·2016-10-26

    Windstone Medical Recalls Lithotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 630 Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2017·2016-10-26

    Windstone Medical Recalls Dr. Casey Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 48 Dr. Casey Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0128-2017·2016-10-26

    Kabobs Mushroom Tart Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Mushroom Tart because it was made with flour contaminated with E. coli O121. The product was distributed across 27 states.

    Product
    MUSHROOM TART, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0142-2017·2016-10-26

    Windstone Medical Recalls Arthroscopy Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 5,723 arthroscopy packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0150-2017·2016-10-26

    Union Bagel Shop Recalls Onion and Garlic Bagels for Undeclared Wheat

    Union Bagel Shop is recalling Onion/Garlic bagels due to undeclared wheat. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Onion/Garlic: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Onion & Garlic Flakes.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0261-2017·2016-10-26

    Windstone Medical Packaging Recalls Plastic General Surgery Kits

    Windstone Medical Packaging is recalling 15 Plastic General Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0174-2017·2016-10-26

    Gourmet Foods Recalls Stretched Coconut Shrimp Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Stretched Coconut Shrimp because the flour used in manufacturing was recalled by General Mills due to potential E. coli contamination.

    Product
    Stretched Coconut Shrimp Pack Size: 180 ea. per case UPC: 22102-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0265-2017·2016-10-26

    Windstone Medical Podiatry Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling specific podiatry kits because included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0173-2017·2016-10-26

    Gourmet Foods Recalls Breaded Cheese Ravioli Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Breaded Cheese Ravioli because it was manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Breaded Cheese Ravioli Pack Size: 1 oz. ea. 15 lb. per case UPC: 18890-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0216-2017·2016-10-26

    Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Lap Gallbladder Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2017·2016-10-26

    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
    Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2017·2016-10-26

    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 surgical kits.

    Product
    C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2017·2016-10-26

    FDA Recalls Windstone Medical Basin Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 1,243 Basin Packs (kit AMS2497) because included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2017·2016-10-26

    Medtronic Disposable Gloves in Laminectomy Kits Recalled for Sterility Risk

    Windstone Medical Packaging is recalling 838 laminectomy kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2017·2016-10-26

    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 Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2017·2016-10-26

    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
    GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0141-2017·2016-10-26

    Kabobs Vegetable Springrolls Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Vegetable Springrolls because they were made with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0222-2017·2016-10-26

    Windstone Medical Recalls Laparotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 1,528 laparotomy packs because disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide