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.

33051–33075 of 50502

  • HighFDA (Devices)·Z-1345-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Morris Hysto Pack, part number PSS3198(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1393-2017·2017-03-08

    Cook Inc. Recalls TriForce Peripheral Crossing Sets Due to Blood Loss Reports

    Cook Inc. is recalling 1,875 TriForce Peripheral Crossing Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral…
    Category
    Medical Device
    Distribution
    46 states
  • HighNHTSA·17V150000·2017-03-08

    Audi Recalls 2017 A5 and S5 Cabriolets for Seat Belt Pretensioner Defect

    Volkswagen Group of America is recalling 2017 Audi A5 and S5 Cabriolets because a seat belt pretensioner component may detach during a crash, creating a projectile hazard.

    Product
    AUDI — AUDI S5 CABRIOLET, A5 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2017·2017-03-08

    Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,056 Laparoscopic Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1344-2017·2017-03-08

    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
    Minor/General/Ortho Pack, part number PSS3258(B
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1391-2017·2017-03-08

    Cook Inc. Recalls Micropuncture Check-Flo Performer Introducer Sets Due to Blood Loss

    Cook Inc. is recalling 778 Micropuncture Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    Micropuncture Check-Flo Performer Introducer Set, 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-1357-2017·2017-03-08

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES Recalled for Sterility Compromise

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

    Product
    Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1340-2017·2017-03-08

    Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 39 Major Pack kits containing Medtronic gloves that may have splits or holes compromising sterility.

    Product
    Major Pack (1345), part number AMS6565
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1354-2017·2017-03-08

    Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 664 Ortho Minor Packs because the included disposable gloves may contain splits or holes that compromise sterility.

    Product
    Ortho Minor Pack, part number AMS3710(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1342-2017·2017-03-08

    Windstone Medical Minor Procedure Packs Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 365 Minor Procedure Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Minor Procedure Pack, part number AMS4799
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1261-2017·2017-03-08

    Windstone Medical Arthroscopy Packs Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 1,081 arthroscopy kits because the disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1305-2017·2017-03-08

    Windstone Medical Packaging Recalls General Packs with Defective Gloves

    Windstone Medical Packaging is recalling 1,501 General Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1390-2017·2017-03-08

    Cook Inc. Recalls Flexor Radial Access Sets Due to Blood Loss Reports

    Cook Inc. is recalling 41,975 Flexor Radial Access Sets because a specific hemostatic valve design is associated with increased reports of blood loss.

    Product
    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
    Category
    Medical Device
    Distribution
    46 states