The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1126–1150 of 2235

  • HighFDA (Devices)·Z-1276-2017·2017-03-08

    Windstone Medical Packaging Recalls Breast Augmentation Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,436 breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part…
    Category
    Medical Device
    Distribution
    26 states
  • 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-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 (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