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.

34226–34250 of 50502

  • HighFDA (Devices)·Z-0240-2017·2016-10-26

    Windstone Medical Recalls Minor Lithotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 114 Minor Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 280 Newport Coast Basic Pack surgical kits because the disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2017·2016-10-26

    Windstone Medical Recalls Transvaginal Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,780 Transvaginal Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 64 surgical kits because gloves inside may have splits or holes that compromise sterility.

    Product
    Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because they may contain splits or holes that compromise sterility.

    Product
    Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0138-2017·2016-10-26

    Kabobs Inc Recalls Crab Cakes Due to E. coli O121 Contamination

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

    Product
    CRAB CAKES, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-0125-2017·2016-10-26

    Kabobs Recalls Mini Mushroom Quiche Due to E. coli O121 Contamination

    Kabobs Inc is recalling Mini Mushroom Quiche because it was manufactured with flour contaminated with E. coli O121.

    Product
    MINI MUSHROOM QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0258-2017·2016-10-26

    Windstone Medical Percutaneous Entry Kits Recalled for Sterility Compromise

    Windstone Medical is recalling Percutaneous Entry Kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2017·2016-10-26

    Windstone Medical Recalls Minor Arthroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 356 Minor Arthroscopy Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2017·2016-10-26

    Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may compromise sterility.

    Product
    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0120-2017·2016-10-26

    Kabobs Recalls Panang Shrimp Prepared with E. coli Contaminated Flour

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

    Product
    PANANG SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0242-2017·2016-10-26

    Windstone Medical Recalls Minor Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,025 minor surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2017·2016-10-26

    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
    Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2017·2016-10-26

    Windstone Medical Recalls Lumbar Laminectomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 249 Lumbar Laminectomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0153-2017·2016-10-26

    Union Bagel Shop Recalls Jalapeno Cheddar Bagels for Undeclared Allergens

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

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Jalapeno Cheddar: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Dried Jalapeno, Organic Cheddar Cheese Powder, Cheddar Cheese.***" 2 bagels per package - plastic bag with…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0157-2017·2016-10-26

    Windstone Medical Brow Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling Brow Pack kits because they may contain defective gloves that compromise sterility.

    Product
    Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0132-2017·2016-10-26

    Kabobs Vegetable Samosa Recalled Due to E. coli O121 Contaminated Flour

    Kabobs Inc is recalling Vegetable Samosa prepared with flour contaminated with E. coli O121. The product was distributed across multiple states.

    Product
    VEGETABLE SAMOSA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0152-2017·2016-10-26

    Windstone Medical Recalls Bayview Breast Packs Due to Sterility Concerns

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

    Product
    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2017·2016-10-26

    Windstone Medical Packaging Recalls Basic Face Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,266 Basic Face Kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2017·2016-10-26

    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
    Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2017·2016-10-26

    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
    D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue

    Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2017·2016-10-26

    Windstone Medical Recalls D & C Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 592 D & C Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide