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.

626–650 of 2228

  • HighFDA (Devices)·Z-0482-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects units distributed worldwide and in the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 265 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects units distributed in the US and internationally.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 80 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2020·2019-11-27

    Cook Inc. Recalls Pneumothorax Trays Due to Sterility Compromise Risk

    Cook Inc. is recalling 41 units of Pneumothorax Trays because a perforation line may be positioned over the sterile area, potentially compromising device sterility.

    Product
    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 135 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls Sterility-Compromised CYP/PROP Vials

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in Ethyl Oleate due to a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings

    Andover Healthcare Inc. is recalling 269 cases of Sterile Co-Flex Med 3" wound dressings due to incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

    Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Seal Issues

    Andover Healthcare Inc. is recalling 1,798 cases of sterile Co-Flex NL 3-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 330 cases of Sterile Co-Flex LF2 3" wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex LF2 Wound Dressings Due to Seal Defects

    Andover Healthcare Inc. is recalling 1,759 cases of sterile Co-Flex LF2 wound dressings because of incomplete packaging seals, which may compromise sterility.

    Product
    Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2020·2019-10-30

    Andover Healthcare Recalls Sterile Co-Flex Med Wound Dressings Due to Packaging Seal Defects

    Andover Healthcare Inc. is recalling 1,050 cases of Sterile Co-Flex Med 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

    Product
    Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2019·2019-09-04

    Stryker Endintrak 2 Hook Blade Recall Due to Compromised Sterile Seal

    Stryker GmbH is recalling 76 units of the Endintrak 2 Hook Blade because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2411-2019·2019-09-04

    Becton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns

    Becton Dickinson is recalling 700 units of Jamshidi Crown Bone Marrow biopsy needles because product pouches may not be sealed properly, potentially compromising sterility.

    Product
    8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2413-2019·2019-09-04

    Stryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity

    Stryker GmbH is recalling 476 Endotrac ECTR Push Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2019·2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 2,248 Endotrac EPF/EGR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2019·2019-09-04

    Stryker Endotrac Push Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 251 Endotrac EPF/EGR Push Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2019·2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blades Due to Seal Integrity Concerns

    Stryker GmbH is recalling 1,959 Endotrac ECTR Hook Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemiu
    Category
    Medical Device
    Distribution
    Distributed nationwide