The Recall Desk

Manufacturer

Galt Medical Corporation

21 recalls in our database name Galt Medical Corporation as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
3
Most recent
2026-08-19

Of the 21 recalls from Galt Medical Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • ModerateFDA (Devices)·Z-2917-2026·2026-08-19

    Galt Medical Recalls Boston Scientific Transcarotid Access Kits

    Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.

    Product
    Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1734-2025·2025-05-14

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2023·2023-06-21

    Tearaway Introducer Kit Recalled Due to Potential Connector Defect

    Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.

    Product
    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2023·2023-06-21

    Tearaway Introducer Set Recall Due to Potential Luer Connection Failure

    Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.

    Product
    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0568-2021·2020-12-23

    Galt Medical Recalls Centeze Centesis Catheters Due to Tip Geometry Defect

    Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.

    Product
    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2558-2018·2018-08-08

    Galt Medical Recalls Sterile Hemostasis Valve Introducer Systems Due to Endotoxins

    Galt Medical Corporation is recalling specific sterile hemostasis valve introducer systems and kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2559-2018·2018-08-08

    Galt Medical Recalls Vascular Dilators and Introducer Kits Due to Endotoxins

    Galt Medical Corporation is recalling specific vascular dilators and introducer kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Te
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2563-2018·2018-08-08

    Galt Medical Recalls Centeze Centesis Catheters Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2560-2018·2018-08-08

    Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

    Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2562-2018·2018-08-08

    Galt Medical Elite HV Introducer Recalled for Bacterial Endotoxins

    Galt Medical Corporation is recalling Elite HV Introducers due to potential unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2561-2018·2018-08-08

    Galt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific sterile transcarotid and peripheral access kits because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2565-2018·2018-08-08

    Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2589-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide