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.

1076–1100 of 2228

  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1478-2017·2017-03-22

    Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal

    Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.

    Product
    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for cov
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1408-2017·2017-03-15

    FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise

    The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.

    Product
    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1409-2017·2017-03-15

    FDA Recalls Premier Guard Drape Due to Sterility Compromise

    The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.

    Product
    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1379-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Upper Torso Tray, part number PSS1554(B
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1368-2017·2017-03-08

    Windstone Medical Packaging Recalls Shoulder Arthroscopy Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 606 Shoulder Arthroscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part nu
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1329-2017·2017-03-08

    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
    Lap/Pelviscopy Pack, part number PSS3256(B
    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-1260-2017·2017-03-08

    Windstone Medical Recalls Anterior Cervical Fusion Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 51 Anterior Cervical Fusion Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1290-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Dr Bragg Vein Tray - RX, part number 007912-8
    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-1344-2017·2017-03-08

    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
    Minor/General/Ortho Pack, part number PSS3258(B
    Category
    Medical Device
    Distribution
    26 states