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.

33076–33100 of 50502

  • HighFDA (Devices)·Z-1298-2017·2017-03-08

    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
    Eye Plastic Tray, part number PSS1931(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1546-2017·2017-03-08

    Bell Stone Toffee Recalls Chocolate Products Due to Undeclared Milk Allergen

    Bell Stone Toffee is voluntarily recalling specific lots of toffee products because the labels failed to identify milk as an ingredient, despite declaring butter.

    Product
    Dark Chocolate Toffee, 2.2oz pouches, 6oz pouches, 7oz boxes, one pound boxes
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1339-2017·2017-03-08

    Windstone Medical Recalls Major Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 32 Major Laparotomy Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Major Laparotomy Pack - NS, part number AMS4347
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1278-2017·2017-03-08

    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
    Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1361-2017·2017-03-08

    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
    Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1385-2017·2017-03-08

    Merge Healthcare Recalls Unity PACS Software Due to Image Error

    Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2017·2017-03-08

    Maquet CARDIOSAVE IABP Li-Ion Battery Recall Due to Venting Risk

    Maquet is recalling Li-Ion batteries for CARDIOSAVE IABP devices after reports of venting when dropped.

    Product
    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2017·2017-03-08

    FDA Recalls Custom Breast Augmentation Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 229 Custom Breast Augmentation Packs because the included gloves may have splits or holes that compromise sterility.

    Product
    Custom Breast Augmentation Pack, part number PSS2455(D
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1253-2017·2017-03-08

    Phadia Recalls EliA Sample Diluent Due to Liquid Level Detection Issues

    Phadia US Inc is recalling EliA Sample Diluent because liquid level detection problems in Phadia 250 instruments caused erroneous test results.

    Product
    EliA Sample Diluent, Article number, 83-1023-01
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1383-2017·2017-03-08

    Synthes Recalls Mislabelled PRODISC Orthopedic Spinal Surgery Struts

    Synthes (USA) Products LLC is recalling two PRODISC Orthopedic Manual Surgical Instrument struts used in spinal surgery because they are incorrectly etched and labeled with the wrong size.

    Product
    PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1381-2017·2017-03-08

    Medtronic Gloves in Custom Kits Recalled for Sterility Compromise

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

    Product
    Vein Tray, part number AMS6312
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1258-2017·2017-03-08

    Windstone Medical Abdominoplasty Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 45 Abdominoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1370-2017·2017-03-08

    Windstone Medical Spine Pack Gloves Recalled for Sterility Compromise

    Windstone Medical Packaging recalled 286 Spine Pack kits because the disposable gloves may contain splits or holes that compromise sterility.

    Product
    Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1341-2017·2017-03-08

    Windstone Medical Minor Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 665 Minor Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
    Category
    Medical Device
    Distribution
    26 states