Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 27 of 548
FDA Devices Critical Jul 16, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Descript…
Edwards Lifesciences, LLC
FDA Devices Moderate Jul 16, 2025
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension fo…
Canary Medical, Inc.
FDA Devices Moderate Jul 16, 2025
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the pe…
Boston Scientific Corporation
FDA Devices Critical Jul 16, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Ed…
Edwards Lifesciences, LLC
FDA Devices Low Jul 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
FDA Devices Critical Jul 16, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edw…
Edwards Lifesciences, LLC
FDA Devices Moderate Jul 16, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VX…
Boston Scientific Corporation
FDA Devices Moderate Jul 16, 2025
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized…
Boston Scientific Corporation
FDA Devices Moderate Jul 16, 2025
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J …
Boston Scientific Corporation
FDA Devices Critical Jul 16, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Prod…
Given Imaging Ltd.
FDA Devices Moderate Jul 16, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachmen…
Alcon Research LLC
FDA Devices Low Jul 16, 2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
STRATASYS LTD
FDA Devices Critical Jul 16, 2025
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product C…
Baxter Healthcare Corporation
FDA Devices Moderate Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Medtronic Navigation, Inc.-Boxborough
CPSC Moderate Jul 10, 2025
SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihu…
Shenzhen Yihuachuang Technology, dba SPPTTY, of China
FDA Devices Moderate Jul 9, 2025
Philips eL18-4 EMT Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
FDA Devices Moderate Jul 9, 2025
Philips C9-5EC Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Critical Jul 9, 2025
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
FDA Devices Moderate Jul 9, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-501…
CORIN MEDICAL, LTD.
FDA Devices Moderate Jul 9, 2025
Philips eL18-4 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
C.R. Bard Inc
FDA Devices Critical Jul 9, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sol…
Philips Respironics, Inc.
FDA Devices Moderate Jul 9, 2025
Philips C5-2 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips L12-3 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips X6-1 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the m…
HemoCue AB
FDA Devices Moderate Jul 9, 2025
Philips X8-2t Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips V6-2 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 9, 2025
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jul 9, 2025
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 …
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jul 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 9, 2025
Philips S5-1 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips S7-2 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips 3D9-3v Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips X7-2t Transducer.
Philips Ultrasound, Inc
FDA Devices Low Jul 9, 2025
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based…
LUMITHERA INC
FDA Devices Moderate Jul 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC0…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Jul 9, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Philips Respironics, Inc.
FDA Devices Moderate Jul 9, 2025
Philips X5-1 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 9, 2025
Philips S8-3t Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips XL14-3 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
Philips C5-1 Transducer.
Philips Ultrasound, Inc
FDA Devices Moderate Jul 9, 2025
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
C.R. Bard Inc
FDA Devices Moderate Jul 9, 2025
Philips L12-4 Transducer.
Philips Ultrasound, Inc
FDA Devices Critical Jul 9, 2025
Servo-n Ventilator System. Model Number: 6694800.
Maquet Critical Care AB
FDA Devices Moderate Jul 9, 2025
Change Healthcare Cardiology Hemo Software
CHANGE HEALTHCARE CANADA COMPANY