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.

34301–34325 of 50502

  • HighFDA (Devices)·Z-0143-2017·2016-10-26

    Windstone Medical Packaging Recalls Augmentation Mammoplasty Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 132 Augmentation Mammoplasty Kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters do not operate within the correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0195-2017·2016-10-26

    Windstone Medical Packaging Recalls General Pack II Surgical Kits

    Windstone Medical Packaging is recalling General Pack II surgical kits because the Medtronic gloves included may contain splits or holes that compromise sterility.

    Product
    General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0127-2017·2016-10-26

    Kabobs Recalls Lobster Pot Pie Due to E. coli O121 Contamination

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

    Product
    LOBSTER POT PIE, 180 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0281-2017·2016-10-26

    Windstone Medical Packaging Recalls Upper Torso Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 546 Upper Torso Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2017·2016-10-26

    Windstone Medical Vein Kit Recall Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Vein Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0155-2017·2016-10-26

    Union Bagel Shop Recalls Bacon Cheddar Bagels for Undeclared Allergens

    Union Bagel Shop is recalling Bacon Cheddar bagels due to undeclared wheat and milk ingredients. The products were distributed to one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Bacon Cheddar: Flour, Filtered Water, Organic Shortening, Bacon Bits, Cheddar Cheese, Green Onions, Malt, Sugar, Sea Salt, Yeast..***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2017·2016-10-26

    Windstone Medical Packaging Recalls Laparotomy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 230 Laparotomy Kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Set-Up Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,225 surgical set-up packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2017·2016-10-26

    Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2017·2016-10-26

    Kabobs Roasted Vegetable Tart Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Roasted Vegetable Tarts because they were made with flour contaminated with E. coli O121.

    Product
    ROASTED VEGETABLE, 200 CT, TART Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-0176-2017·2016-10-26

    Gourmet Foods Recalls Shrimp Products Due to E. coli Contamination

    Gourmet Foods is recalling frozen shrimp products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Shrimp 21/25 Coconut Butterfly Pack Size: 200 ea. per case UPC: 23502-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0137-2017·2016-10-26

    Merge Healthcare CADstream software recall for missing PURE filter message

    Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.

    Product
    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2017·2016-10-26

    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
    Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2017·2016-10-26

    Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone custom surgical kits because the gloves may contain splits or holes that compromise sterility.

    Product
    Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2017·2016-10-26

    Windstone Medical Recalls Laparoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 184 laparoscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2017·2016-10-26

    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
    Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0172-2017·2016-10-26

    Gourmet Foods Recalls Strudel Wild Mushroom Due to E. coli Risk

    Gourmet Foods, Inc. is recalling Strudel Wild Mushroom products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.

    Product
    Strudel Wild Mushroom Pack Size: 240 ea. per case UPC: 17338-03 Keep Frozen: Gourmet Foods, Hayward, CA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0218-2017·2016-10-26

    Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2017·2016-10-26

    Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise

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

    Product
    Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2017·2016-10-26

    Windstone Medical recalls surgical kits with defective disposable gloves

    Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.

    Product
    Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0145-2017·2016-10-26

    Kabobs Mozzarella Calzone Recalled Due to E. coli O121 Contamination

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

    Product
    MOZZARELLA CALZONE, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states