Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Medical Devices·1,086 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Medical Devices·763 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Medical Devices·259 affected·Jun 2, 2014
High RiskFDA
B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Medical Devices·10,835 affected·May 29, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive ...
Medical Devices·659 affected·May 29, 2014
High RiskFDA
Kerr Corporation
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a...
Medical Devices·2,030 affected·May 29, 2014
High RiskFDA
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 3...
Medical Devices·224 affected·May 29, 2014
High RiskFDA
Shape Medical Systems, Inc
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-40...
Medical Devices·800 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous eval...
Medical Devices·164 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evalua...
Medical Devices·147 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous ev...
Medical Devices·34 affected·May 28, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarn...
Medical Devices·7,460 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: ...
Medical Devices·7,190 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula ...
Medical Devices·6,720 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Ven...
Medical Devices·34,470 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusio...
Medical Devices·120 affected·May 23, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among h...
Medical Devices·723 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion o...
Medical Devices·3,040 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: ...
Medical Devices·2,290 affected·May 23, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; R...
Medical Devices·20,507 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicate...
Medical Devices·135,340 affected·May 23, 2014
High RiskFDA
Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Medical Devices·42,600 affected·May 22, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices·17 affected·May 21, 2014
High RiskFDA
Teleflex Medical
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular devi...
Medical Devices·1,000 affected·May 21, 2014
High RiskFDA
Stryker Endoscopy
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Medical Devices·1,992 affected·May 19, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. T...
Medical Devices·113 affected·May 19, 2014
High RiskFDA
Kci Usa, Inc.
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Medical Devices·1,331 affected·May 19, 2014
High RiskFDA
Alcon Research, Ltd.
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-...
Medical Devices·684 affected·May 16, 2014
Medium RiskFDA
Medtest Holdings, Inc.
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black ...
Medical Devices·132,919 affected·May 15, 2014
High RiskFDA
Ebi, Llc
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Medical Devices·32 affected·May 15, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for ...
Medical Devices·681 affected·May 14, 2014
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies use...
Medical Devices·2 affected·May 12, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed int...
Medical Devices·1 affected·May 9, 2014
CriticalFDA
Siemens Medical Solutions Usa, Inc
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems desig...
Medical Devices·10 affected·May 9, 2014
High RiskFDA
Varian Medical Systems Particle Therapy Gmbh
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy o...
Medical Devices·1 affected·May 9, 2014
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with t...
Medical Devices·64 affected·May 8, 2014
High RiskFDA
The Anspach Effort, Inc.
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Medical Devices·115,988 affected·May 8, 2014
High RiskFDA
Advanced Photonic Systems, Llc
Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PR...
Medical Devices·235 affected·May 6, 2014
High RiskFDA
Advanced Photonic Systems, Llc
Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, Ul...
Medical Devices·235 affected·May 6, 2014
High RiskFDA
Advanced Photonic Systems, Llc
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO...
Medical Devices·235 affected·May 6, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accele...
Medical Devices·108 affected·May 6, 2014
High RiskFDA
Beaver-visitec International Inc.
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic soluti...
Medical Devices·9,970 affected·May 6, 2014
High RiskFDA
Philips Healthcare Informatics, Inc.
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a compu...
Medical Devices·5 affected·May 5, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, ret...
Medical Devices·659 affected·May 5, 2014
High RiskFDA
Varian Medical Systems, Inc.
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in rel...
Medical Devices·32 affected·Apr 30, 2014
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
Medical Devices·249 affected·Apr 30, 2014
High RiskFDA
Childrens Medical Ventures
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Medical Devices·112 affected·Apr 29, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K...
Medical Devices·39 affected·Apr 25, 2014