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
Recalls in Texas
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–105 of 105 recalls
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
Class IIOngoingZ-0835-2025
Alcon Research LLC recalls Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Numbe…
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
Alcon Research LLCTXJan 22, 2025
Class IIOngoingZ-0766-2025
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXJan 1, 2025
Class IIOngoingZ-0761-2025
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXJan 1, 2025