The Recall Desk

FDA (Devices) recall action 96622

Galt Medical Corporation recalled 7 products on 2025-05-14

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2025-05-14
Critical
0
Units
9,451

Why these products were recalled

Due to a potential open seal in the sterile barrier packaging.

Due to a potential open seal in the sterile barrier packaging .

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.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2025-05-14

    Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue

    Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.

    Product
    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2025-05-14

    GALT Guidewire SGW-051-07 Sterile Packaging Seal Defect Recall

    Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2025-05-14

    GALT Centeze Catheter recalled due to potential sterile packaging seal failure

    Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.

    Product
    GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2025-05-14

    Introducer Kit-Tearaway MicroSlide Medical Device Recall

    Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.

    Product
    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2025-05-14

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall

    Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2025-05-14

    Introducer Needle REF NDL-107-04 Sterile Packaging Recall

    Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.

    Product
    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2025-05-14

    B Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall

    Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.

    Product
    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
    Category
    Distribution
    8 states