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.

1351–1375 of 2228

  • HighFDA (Devices)·Z-0161-2017·2016-10-26

    Windstone Medical Recalls Cardiac Cath Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 138 Cardiac Cath Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits

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

    Product
    Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2017·2016-10-26

    Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2017·2016-10-26

    Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2017·2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 general surgery kits because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2017·2016-10-26

    Windstone Medical Packaging Recalls Dr Mullins Surgical Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2017·2016-10-26

    Medtronic Disposable Gloves in Laminectomy Kits Recalled for Sterility Risk

    Windstone Medical Packaging is recalling 838 laminectomy kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2017·2016-10-26

    Windstone Medical Recalls Arthroscopy Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 5,723 arthroscopy packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2017·2016-10-26

    Windstone Medical Packaging Recalls Laparotomy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 230 Laparotomy Kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,164 custom surgical kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves used in custom surgical kits because splits or holes may compromise sterility.

    Product
    Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 64 surgical kits because gloves inside may have splits or holes that compromise sterility.

    Product
    Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.

    Product
    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2017·2016-10-26

    Windstone Medical Recalls Ortho Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 92 Ortho Pack kits because they may contain defective gloves with splits or holes that compromise sterility.

    Product
    Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2017·2016-10-26

    Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise

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

    Product
    Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2017·2016-10-26

    Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Lap Gallbladder Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2017·2016-10-26

    Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide