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.

33026–33050 of 50502

  • HighFDA (Devices)·Z-1291-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Dr. Casey Pack, part number AMS4313(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1389-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Hemostasis Assemblies Due to Blood Loss Reports

    Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.

    Product
    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1264-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

    Product
    Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1311-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

    Product
    Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1259-2017·2017-03-08

    Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 174 Angio Pack kits because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Angio Pack, part number AMS6711
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1266-2017·2017-03-08

    Windstone Medical Packaging Recalls Basic Kits with Defective Gloves

    Windstone Medical Packaging is recalling 216 Basic Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Basic Kit, part number CMP1109(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1356-2017·2017-03-08

    Windstone Medical Recalls Pacemaker Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 561 pacemaker kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1544-2017·2017-03-08

    World Organic Recalls Vitamins Due to Allergen Labeling Errors

    World Organic Corp. is recalling Theravits 100 and The Supreme One vitamins because the labels incorrectly state they contain no common allergens while containing fish liver oil.

    Product
    Theravits 100, container sizes: 30, 60, 90, 180, Product Code: 0783-30, 0786-60, 0789-90, 0788-180; The Supreme One, Container sizes: 30,60,90,180, Product Code: 680-030, 680-060, 680-090, 680-180. The Supreme One and Theravits 100 product is sold under the brand names of…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1387-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports

    Cook Inc. is recalling 884 Check-Flo Performer Introducers because a specific valve design is associated with increased reports of blood loss.

    Product
    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1315-2017·2017-03-08

    Windstone Medical Recalls Hernia Packs with Defective Gloves

    Windstone Medical Packaging is recalling 228 Hernia Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Hernia Pack, part number AMS3859
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1292-2017·2017-03-08

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

    Windstone Medical Packaging is recalling 944 Dr. Landi EVLT Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1284-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1319-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1364-2017·2017-03-08

    Windstone Medical Packaging Recalls Reduction Mammoplasty Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 35 Reduction Mammoplasty Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1324-2017·2017-03-08

    Medtronic Gloves in AMS Lap Band Kits Recalled for Sterility Risk

    Windstone Medical Packaging is recalling 252 Lap Band kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lap Band Pack, part number AMS1785(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1336-2017·2017-03-08

    Windstone Medical Recalls Lumbar Laminectomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 123 Lumbar Laminectomy Packs because the included gloves may have splits or holes that compromise sterility.

    Product
    Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
    Category
    Medical Device
    Distribution
    26 states