The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 2228

  • HighFDA (Devices)·Z-1332-2017·2017-03-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 331 laparotomy packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1380-2017·2017-03-08

    Windstone Medical Recalls Vascular Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 360 Vascular Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(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-1267-2017·2017-03-08

    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 Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
    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-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-1277-2017·2017-03-08

    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
    Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272
    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-1269-2017·2017-03-08

    Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 276 Basic Setup Packs because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
    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-1294-2017·2017-03-08

    Windstone Medical ENT Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 390 ENT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
    Category
    Medical Device
    Distribution
    26 states