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.

34251–34275 of 50502

  • HighFDA (Devices)·Z-0154-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2017·2016-10-26

    Windstone Medical Recalls Hall SAP Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 30 Hall SAP surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2017·2016-10-26

    Windstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns

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

    Product
    Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2017·2016-10-26

    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
    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0122-2017·2016-10-26

    Kabobs Mini Florentine Quiche Recalled for E. coli O121 Contamination

    Kabobs Inc is recalling Mini Florentine Quiche because it was manufactured with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    MINI FLORENTINE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0288-2017·2016-10-26

    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
    Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2017·2016-10-26

    Windstone Medical Recalls Knee Scope Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 272 Knee Scope Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2017·2016-10-26

    Windstone Medical Packaging Recalls Dr Mullins Surgical Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0223-2017·2016-10-26

    Windstone Medical Recalls Laparotomy Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.

    Product
    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0159-2017·2016-10-26

    Union Bagel Shop Jalapeno Bread Recalled for Undeclared Allergens

    Union Bagel Shop is recalling Jalapeno Bread for containing undeclared wheat and milk. The product was sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***JALAPENO BREAD *** Filtered Water,Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter & Dried Jalapenos***" plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0276-2017·2016-10-26

    Windstone Medical Recalls Total Joint Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 58 Total Joint Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2017·2016-10-26

    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
    Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0144-2017·2016-10-26

    Kabobs Recalls Shrimp Springrolls Due to E. coli O121 Contamination

    Kabobs Inc is recalling shrimp springrolls prepared with flour contaminated with E. coli O121. The product was distributed to multiple states.

    Product
    SHRIMP SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0202-2017·2016-10-26

    Windstone Medical GYN-Laparoscopy Tray Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling GYN-Laparoscopy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2017·2016-10-26

    Windstone Medical Recalls Cardiac Cath Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 138 Cardiac Cath Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0158-2017·2016-10-26

    Union Bagel Shop Recalls Cinnamon Raisin Bagels for Undeclared Allergens

    Union Bagel Shop is recalling cinnamon raisin bagels sold in Oregon due to undeclared wheat and milk ingredients.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***CINNAMON RAISIN*** Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter Cinnamon & Raisins***" plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0137-2017·2016-10-26

    Kabobs Coconut Shrimp Recalled Due to E. coli O121 Contaminated Flour

    Kabobs Inc is recalling Coconut Shrimp because it was manufactured with flour recalled for E. coli O121 contamination.

    Product
    COCONUT SHRIMP, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0171-2017·2016-10-26

    Windstone Medical Recalls D&C/GYN/Hysteroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 56 D&C/GYN/Hysteroscopy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2017·2016-10-26

    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
    Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits

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

    Product
    Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2017·2016-10-26

    Windstone Medical Recalls Minor Ortho Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Minor Ortho Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2017·2016-10-26

    Windstone Medical Recalls Universal Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide