The Recall Desk

FDA (Devices) recall action 83423

Stryker GmbH recalled 13 products on 2019-09-04

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products
13
Announced
2019-09-04
Critical
0
Units
7,143

Why these products were recalled

The seal integrity of the sterile bag containing the kits may be compromised.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

  • ModerateFDA (Devices)··2019-09-04

    Stryker Endotrac Hook Blade Recalled for Compromised Sterile Bag Seal

    Stryker GmbH is recalling 110 units of Endotrac EPF/EGR Hook Blades because the sterile bag seal integrity may be compromised.

    Product
    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-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…
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    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Endotrac ECTR Triangle Blade Recalled Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 53 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Catalog Number 2054-1 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…
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    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Recalls Endintrak 2 Hook Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 259 Endintrak 2 Hook Blade kits because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-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…
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    0 states
  • ModerateFDA (Devices)··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…
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    Distribution
    0 states
  • HighFDA (Devices)··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…
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    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Recalls Endotrac ECTR Triangle Blades Due to Seal Integrity

    Stryker GmbH is recalling 94 Endotrac ECTR Triangle Blades because the sterile bag seal may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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…
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    Distribution
    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Recalls Endotrac ECTR Hook Blade Kits Due to Seal Integrity

    Stryker GmbH is recalling 28 Endotrac ECTR Hook Blade kits because the sterile bag seal integrity may be compromised.

    Product
    Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Recalls Endotrig ETF Hook Blades Due to Sterile Seal Concerns

    Stryker GmbH is recalling 35 Endotrig ETF Hook Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrig ETF Hook Blade, Catalog Number 1052-1 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…
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    Distribution
    0 states
  • ModerateFDA (Devices)··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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-04

    Stryker Endotrac EPF/EGR Triangle Blade Recall for Compromised Sterile Seal

    Stryker GmbH is recalling 21 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, posing a risk of contamination.

    Product
    Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-09-04

    Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 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…
    Category
    Distribution
    0 states