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.

34351–34375 of 50502

  • HighFDA (Devices)·Z-0207-2017·2016-10-26

    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
    Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2017·2016-10-26

    Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2017·2016-10-26

    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
    Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2017·2016-10-26

    Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns

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

    Product
    Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17706·2016-10-26

    Hearth & Home Technologies Recalls Quadra Fire Explorer III Wood Stoves

    Hearth & Home Technologies is recalling about 650 Quadra Fire Explorer III wood stoves because the top lid handle can disengage, causing the lid to slam shut on fingers.

    Product
    Quadra Fire® Explorer III wood stoves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters are not operating within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0230-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising sterility.

    Product
    Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2017·2016-10-26

    Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2017·2016-10-26

    Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

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

    Product
    Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2017·2016-10-26

    Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2017·2016-10-26

    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
    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0148-2017·2016-10-26

    Union Bagel Shop Recalls Cinnamon Raisin Bagels Due to Undeclared Wheat

    Union Bagel Shop is recalling Cinnamon Raisin Bagels because the packaging fails to declare wheat as an ingredient. The products were sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Cinnamon Raisin: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Cinnamon, Raisin***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0264-2017·2016-10-26

    Windstone Medical Recalls Podiatry Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 545 podiatry kits because disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2017·2016-10-26

    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
    General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2017·2016-10-26

    Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 430 Peri GYN surgical kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2017·2016-10-26

    Medtronic Disposable Surgical 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
    Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0131-2017·2016-10-26

    Kabobs Recalls Shrimp Empanadas Due to E. coli O121 Contamination

    Kabobs Inc is recalling Shrimp Empanadas because they were manufactured with flour contaminated with E. coli O121.

    Product
    SHRIMP EMPANADA Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0254-2017·2016-10-26

    Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 160 Ortho Minor Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2017·2016-10-26

    Windstone Medical Recalls Shoulder Arthroscopy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2017·2016-10-26

    Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves used in custom surgical kits because splits or holes may compromise sterility.

    Product
    Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2017·2016-10-26

    Synergetics Recalls 25 Gauge VersaVit 2.0 Vitrectomy Cutters

    Synergetics Inc is recalling 25 gauge VersaVit 2.0 Vitrectomy Cutters because they may not operate within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0208-2017·2016-10-26

    Windstone Medical Recalls Hernia Packs With Defective Gloves

    Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2017·2016-10-26

    Windstone Medical Recalls Laparoscopy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide