Class IIOngoingZ-1734-2025
Galt Medical Corporation recalls GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous proce…
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025
Recalls in Texas
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–84 of 87 recalls
Class IIOngoingZ-1733-2025
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model N…
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1732-2025
Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1731-2025
Galt Medical Corporation recalls GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use…
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1432-2025
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Orthofix U.S. LLCTXApr 2, 2025
Class IIOngoingZ-1293-2025
Alcon Research LLC recalls Alcon Custom Pak with Non-Latex Symbol
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product.…
Alcon Research LLCTXMar 12, 2025
Class IIOngoingZ-1176-2025
KCI USA, INC. recalls 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VI…
Due to increase in complaints related to leak alarms
KCI USA, INC.TXFeb 26, 2025
Class IIOngoingZ-1175-2025
KCI USA, INC. recalls 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel…
Due to increase in complaints related to leak alarms
KCI USA, INC.TXFeb 26, 2025
Class IIOngoingZ-1073-2025
LivaNova USA, Inc. recalls SenTiva
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizur…
LivaNova USA, Inc.TXFeb 12, 2025
Class IIOngoingZ-1072-2025
LivaNova USA, Inc. recalls SenTiva
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizur…
LivaNova USA, Inc.TXFeb 12, 2025
Class IIOngoingZ-1068-2025
LivaNova USA, Inc. recalls Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO"
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
LivaNova USA, Inc.TXFeb 5, 2025
Class IIOngoingZ-1067-2025
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva"
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
LivaNova USA, Inc.TXFeb 5, 2025