Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 122 of 548
FDA Devices Moderate Apr 5, 2023
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Preat Corp
FDA Devices Moderate Apr 5, 2023
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-fre…
Entopsis , Inc.
FDA Devices Moderate Apr 5, 2023
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Baxter Healthcare Corporation
FDA Devices Moderate Apr 5, 2023
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Defibtech, LLC
FDA Devices Moderate Apr 5, 2023
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Entopsis , Inc.
FDA Devices Moderate Apr 5, 2023
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Fujifilm Irvine Scientific, Inc.
FDA Devices Moderate Apr 5, 2023
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select appl…
Entopsis , Inc.
FDA Devices Moderate Apr 5, 2023
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE…
Alcon Research, LLC
FDA Devices Moderate Apr 5, 2023
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Intuitive Surgical, Inc.
FDA Devices Moderate Apr 5, 2023
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Atrium Medical Corporation
FDA Devices Moderate Apr 5, 2023
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucl…
Entopsis , Inc.
FDA Devices Moderate Apr 5, 2023
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing …
Quidel Corporation
FDA Devices Moderate Apr 5, 2023
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu…
Stryker Sustainability Solutions
FDA Devices Moderate Apr 5, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0…
Instrumentation Laboratory
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
DePuy Orthopaedics, Inc.
FDA Devices Moderate Mar 29, 2023
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Biomet, Inc.
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
DePuy Orthopaedics, Inc.
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
DePuy Orthopaedics, Inc.
FDA Devices Moderate Mar 29, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
FDA Devices Moderate Mar 29, 2023
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0,…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Mar 29, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45…
Datascope Corp.
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
DePuy Orthopaedics, Inc.
FDA Devices Moderate Mar 29, 2023
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
DeRoyal Industries Inc
FDA Devices Moderate Mar 29, 2023
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Withings
FDA Devices Moderate Mar 29, 2023
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
CooperVision, Inc.
CPSC Moderate Mar 23, 2023
Kawasaki Motors USA Recalls Engines Sold on Ferris and SCAG Riding Lawn Mowers Due to Burn and Fire Hazards
Kawasaki Motors Manufacturing Corp. USA, of Maryville, Mo.
FDA Drug Low Mar 22, 2023
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Labora…
Padagis US LLC
FDA Devices Moderate Mar 22, 2023
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in …
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652,…
Intuitive Surgical, Inc.
FDA Devices Moderate Mar 22, 2023
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Limacorporate S.p.A
FDA Devices Moderate Mar 22, 2023
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catal…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …
Synthes (USA) Products LLC
FDA Devices Moderate Mar 22, 2023
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Mar 22, 2023
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Brainlab AG
FDA Devices Moderate Mar 22, 2023
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Fenwal Inc
FDA Devices Moderate Mar 22, 2023
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Cata…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. …
Synthes (USA) Products LLC
FDA Devices Moderate Mar 22, 2023
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Scientia Vascular, Inc.
FDA Devices Moderate Mar 22, 2023
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in t…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalo…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog N…
Becton Dickinson & Company
FDA Devices Moderate Mar 22, 2023
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
BioFire Diagnostics, LLC
FDA Devices Moderate Mar 22, 2023
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Fenwal Inc
FDA Devices Moderate Mar 22, 2023
Recreo Hair Growth Laser Comb
OMM Imports, Inc. dba Zero Gravity
FDA Devices Moderate Mar 22, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Imm…
Beckman Coulter, Inc.
FDA Drug Moderate Mar 15, 2023
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Denver Solutions, LLC DBA Leiters Health
FDA Drug Moderate Mar 15, 2023
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Denver Solutions, LLC DBA Leiters Health
FDA Devices Moderate Mar 15, 2023
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrason…
Sensus Healthcare, Inc.
FDA Devices Moderate Mar 15, 2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data use…
St. Jude Medical