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.

1326–1350 of 2228

  • HighFDA (Devices)·Z-0244-2017·2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2017·2016-10-26

    Windstone Medical Percutaneous Entry Kits Recalled for Sterility Compromise

    Windstone Medical is recalling Percutaneous Entry Kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2017·2016-10-26

    Windstone Medical Recalls Dr. Fetters Hand Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2017·2016-10-26

    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
    Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2017·2016-10-26

    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
    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2017·2016-10-26

    Windstone Medical Knee Packs Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits

    Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2017·2016-10-26

    Windstone Medical Breast Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2017·2016-10-26

    Windstone Medical Recalls Cath Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2017·2016-10-26

    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 Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2017·2016-10-26

    Windstone Medical Recalls Knee Scope Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 272 Knee Scope Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2017·2016-10-26

    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
    Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2017·2016-10-26

    Windstone Medical Recalls Lithotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 630 Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2017·2016-10-26

    Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 160 Ortho Minor Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2017·2016-10-26

    Windstone Medical Recalls Minor Arthroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 356 Minor Arthroscopy Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2017·2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise

    ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.

    Product
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0250-2017·2016-10-26

    Windstone Medical Recalls OB/GYN Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 18 OB/GYN kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2017·2016-10-26

    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
    C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2017·2016-10-26

    Windstone Medical Packaging Recalls Plastic General Surgery Kits

    Windstone Medical Packaging is recalling 15 Plastic General Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2017·2016-10-26

    Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2017·2016-10-26

    Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

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

    Product
    Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2017·2016-10-26

    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
    Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2017·2016-10-26

    Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2017·2016-10-26

    Windstone Medical Recalls Foot Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Foot Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide