Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
United Surgical Associates
Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremitie...
Medical Devices·1,278 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
Medical Devices·177 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
Medical Devices·72 affected·Apr 13, 2015
High RiskFDA
United Surgical Associates
Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities...
Medical Devices·1,260 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
Medical Devices·92 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
Medical Devices·78 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.
Medical Devices·118 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
Medical Devices·91 affected·Apr 13, 2015
High RiskFDA
Coopersurgical, Inc.
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during...
Medical Devices·9,400 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
Medical Devices·796 affected·Apr 13, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital...
Medical Devices·133 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
Medical Devices·353 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
Medical Devices·138 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
Medical Devices·686 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
Medical Devices·80 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
Medical Devices·99 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
Medical Devices·88 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
Medical Devices·189 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
Medical Devices·88 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
Medical Devices·69 affected·Apr 13, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Medical Devices·2 affected·Apr 13, 2015
High RiskFDA
The Anspach Effort, Inc.
ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
Medical Devices·79 affected·Apr 13, 2015
High RiskFDA
Alphatec Spine, Inc.
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical...
Medical Devices·244 affected·Apr 10, 2015
High RiskFDA
Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number...
Medical Devices·2,472 affected·Apr 10, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite software. Radiological image processing system.
Medical Devices·10 affected·Apr 9, 2015
High RiskFDA
Bte Technologies, Inc.
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and pass...
Medical Devices·510 affected·Apr 9, 2015
High RiskFDA
Bard Peripheral Vascular Inc
BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a...
Medical Devices·7,995 affected·Apr 9, 2015
RecallFDA
Spinal Elements, Inc
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods...
Medical Devices·588 affected·Apr 9, 2015
High RiskFDA
Synthes, Inc.
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Medical Devices·8,175 affected·Apr 9, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in ...
Medical Devices·155 affected·Apr 9, 2015
High RiskFDA
Baxter Corporation Englewood
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-base...
Medical Devices·882 affected·Apr 8, 2015
High RiskFDA
X Spine Systems Inc
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone...
Medical Devices·75 affected·Apr 7, 2015
CriticalFDA
Winco Mfg., Llc
Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Medical Devices·1 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Medical Devices·30 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Medical Devices·1 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement ...
Medical Devices·1 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physic...
Medical Devices·32 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Medical Devices·4 affected·Apr 2, 2015
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult pat...
Medical Devices·1,641 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilit...
Medical Devices·1 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis...
Medical Devices·1 affected·Apr 2, 2015
CriticalFDA
Winco Mfg., Llc
Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Medical Devices·1 affected·Apr 2, 2015
High RiskFDA
Viewray Incorporated
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy...
Medical Devices·3 affected·Apr 1, 2015
High RiskFDA
Nipro Medical Corporation
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to ...
Medical Devices·1,484 affected·Mar 30, 2015
High RiskFDA
Merge Healthcare, Inc.
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separat...
Medical Devices·23 affected·Mar 30, 2015
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catal...
Medical Devices·90 affected·Mar 30, 2015
High RiskFDA
Biomerieux Inc
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in cli...
Medical Devices·43,535 affected·Mar 27, 2015
High RiskFDA
B. Braun Medical, Inc.
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Cust...
Medical Devices·5,000 affected·Mar 27, 2015