The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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.

1201–1225 of 2235

  • 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-1285-2017·2017-03-08

    Windstone Medical Packaging Recalls Custom Kits with Defective Gloves

    Windstone Medical Packaging is recalling 840 custom kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Custom Pack - with Introducer Kit, part number TVS4011NI(L
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1346-2017·2017-03-08

    Windstone Medical Recalls Morris Lap Packs Due to Sterility Compromise

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

    Product
    Morris Lap Pack, part number PSS3199(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1320-2017·2017-03-08

    Windstone Medical Recalls Knee Arthroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 700 knee arthroscopy packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1297-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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

    Product
    Extremity Pack-N Brunswick, part number PSS1866(A
    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…
    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-1233-2017·2017-03-01

    Degania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise

    Degania Silicone is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round because the sterile barrier was breached, compromising sterility.

    Product
    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1194-2017·2017-02-22

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2017·2017-02-22

    Argon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling T-LOK bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2017·2017-02-22

    Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns

    Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1136-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 105 Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility. The recall affects units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1132-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 499 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 275 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 180 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide