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.

1276–1300 of 2228

  • HighFDA (Devices)·Z-0179-2017·2016-10-26

    Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside may contain splits or holes that compromise sterility.

    Product
    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0224-2017·2016-10-26

    Windstone Medical Recalls Lipo Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 40 Lipo Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2017·2016-10-26

    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
    Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2017·2016-10-26

    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
    Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2017·2016-10-26

    Windstone Medical Packaging Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 985 general surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may compromise sterility.

    Product
    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2017·2016-10-26

    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
    Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2017·2016-10-26

    Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2017·2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 General Pack I surgery kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2017·2016-10-26

    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
    Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2017·2016-10-26

    Windstone Medical Recalls Total Joint Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 58 Total Joint Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2017·2016-10-26

    Windstone Medical Recalls D&C/GYN/Hysteroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 56 D&C/GYN/Hysteroscopy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2017·2016-10-26

    Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2017·2016-10-26

    Windstone C-Section Kits Recalled Due to Potential Glove Splits or Holes

    Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2017·2016-10-26

    Windstone Medical GYN-Laparoscopy Tray Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling GYN-Laparoscopy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2017·2016-10-26

    Windstone Medical recalls surgical kits with defective disposable gloves

    Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.

    Product
    Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2017·2016-10-26

    Windstone Medical Recalls D & C Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 592 D & C Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2017·2016-10-26

    Windstone Medical Packaging Recalls Upper Torso Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 546 Upper Torso Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2017·2016-10-26

    Windstone Medical Packaging Recalls Mohs Closer Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 340 Mohs Closer Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0270-2017·2016-10-26

    Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2017·2016-10-26

    Windstone Medical Recalls Minor Ortho Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Minor Ortho Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2017·2016-10-26

    Windstone Medical Vein Kit Recall Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Vein Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

    The FDA is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone Medical Packaging facial plastic kits because the gloves may contain splits or holes that compromise sterility.

    Product
    Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide