Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Hand Biomechanics Lab Inc
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and ex...
Medical Devices·65 affected·Sep 14, 2016
High RiskFDA
Varian Medical Systems, Inc.
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is f...
Medical Devices·75 affected·Sep 13, 2016
CriticalFDA
Contour Fabricators Inc
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
Medical Devices·447 affected·Sep 9, 2016
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech In...
Medical Devices·1,278 affected·Sep 8, 2016
High RiskFDA
Banyan Medical, Llc
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Medical Devices·64 affected·Sep 7, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture Archiving and Communication System
Medical Devices·47 affected·Sep 6, 2016
High RiskFDA
Heritage Medical Products, Inc.
2000 Vascular with 30 Degree option
Medical Devices·167 affected·Sep 2, 2016
High RiskFDA
Cellera Llc
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Medical Devices·2,110 affected·Sep 1, 2016
High RiskFDA
Ormco/sybronendo
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intend...
Medical Devices·179 affected·Aug 31, 2016
High RiskFDA
Neusoft Medical Systems Co., Ltd.
NeuViz 64 Multi-slice CT Scanner Systems
Medical Devices·23 affected·Aug 31, 2016
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model number...
Medical Devices·17,964 affected·Aug 30, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with...
Medical Devices·200 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 7132...
Medical Devices·2,352 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044,...
Medical Devices·5,806 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog N...
Medical Devices·153 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with ...
Medical Devices·75 affected·Aug 29, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·88 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Medical Devices·63 affected·Aug 26, 2016
CriticalFDA
Teleflex Medical
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and n...
Medical Devices·1,095 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·69 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Medical Devices·177 affected·Aug 26, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Centr...
Medical Devices·316 affected·Aug 25, 2016
High RiskFDA
Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Medical Devices·1,297 affected·Aug 25, 2016
High RiskFDA
Natus Medical Incorporated
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-S...
Medical Devices·104 affected·Aug 25, 2016
High RiskFDA
United Nuclear Scientific Supplies, Llc
United Nuclear Scientific High Power Handheld Lasers. Laser products
Medical Devices·3 affected·Aug 25, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibi...
Medical Devices·798 affected·Aug 25, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs ...
Medical Devices·320 affected·Aug 24, 2016
High RiskFDA
Philips Medical Systems
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b...
Medical Devices·358 affected·Aug 24, 2016
High RiskFDA
Philips Medical Systems
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b...
Medical Devices·235 affected·Aug 24, 2016
CriticalFDA
Baxter Corporation Englewood
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches...
Medical Devices·202,647 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Medical Devices·710 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged...
Medical Devices·1 affected·Aug 23, 2016
High RiskFDA
Integra Lifesciences Corp.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyve...
Medical Devices·9 affected·Aug 23, 2016
High RiskFDA
Ekos Corporation
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic ...
Medical Devices·455 affected·Aug 22, 2016
High RiskFDA
Brathwaites Oliver Medical
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide dur...
Medical Devices·760 affected·Aug 19, 2016
High RiskFDA
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray i...
Medical Devices·13,340 affected·Aug 19, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, US...
Medical Devices·3,768 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of...
Medical Devices·13 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·3,012 affected·Aug 18, 2016
High RiskFDA
Lsi Medience Corporation
Pathfast D-Dimer, Reference number: PF1051-KUS
Medical Devices·42 affected·Aug 16, 2016
High RiskFDA
Prismatik Dentalcraft, Inc
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated...
Medical Devices·150 affected·Aug 15, 2016
RecallFDA
Arthrex, Inc.
Arthrex Suture Washer
Medical Devices·45 affected·Aug 12, 2016
CriticalFDA
Philips Electronics North America Corporation
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing ...
Medical Devices·388 affected·Aug 12, 2016
High RiskFDA
Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging softw...
Medical Devices·1 affected·Aug 12, 2016
High RiskFDA
Sorin Group Usa, Inc.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be ...
Medical Devices·200 affected·Aug 12, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320...
Medical Devices·2,910 affected·Aug 11, 2016
High RiskFDA
Synergetics Inc
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile ba...
Medical Devices·72 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
Medical Devices·2,602 affected·Aug 11, 2016