Galt Medical Recalls
21 recalls on record · September 10, 2014 to August 19, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026Medical DevicesFDA
Galt Medical Corporation recalls Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Sti
Hazard: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers ar
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 0084126810480
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV
Hazard: Due to a potential open seal in the sterile barrier packaging .
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce
Hazard: Due to a potential open seal in the sterile barrier packaging .
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations
Hazard: Due to a potential open seal in the sterile barrier packaging .
June 21, 2023Medical DevicesFDA
Galt Medical Corporation recalls 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-01
Hazard: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
June 21, 2023Medical DevicesFDA
Galt Medical Corporation recalls Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Hazard: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
December 23, 2020Medical DevicesFDA
Galt Medical Corporation recalls Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF
Hazard: Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls 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
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls TVS LPA, Catalog #: DIL-059-00
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls 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 T
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Cent
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
August 8, 2018Medical DevicesFDA
Galt Medical Corporation recalls 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-10
Hazard: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
September 10, 2014Medical DevicesFDA
Galt Medical Corporation recalls GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product
Hazard: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
September 10, 2014Medical DevicesFDA
Galt Medical Corporation recalls GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous p
Hazard: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.