Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston...
Medical Devices·740 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter ...
Medical Devices·4 affected·Nov 20, 2013
High RiskFDA
Sorin Group Italia S.r.l.
ORCHESTRA/ORCHESTRA PLUS Programmer
Medical Devices·1,718 affected·Nov 20, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Dr...
Medical Devices·211 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK -...
Medical Devices·153 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, S...
Medical Devices·45 affected·Nov 20, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distribu...
Medical Devices·1,979 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050...
Medical Devices·10,448 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). ...
Medical Devices·352 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100...
Medical Devices·954 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manu...
Medical Devices·246 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manuf...
Medical Devices·834 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors...
Medical Devices·361 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distri...
Medical Devices·454 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-...
Medical Devices·42,699 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P...
Medical Devices·1,944 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-3...
Medical Devices·1,002 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distribu...
Medical Devices·1,392 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-3...
Medical Devices·6,684 affected·Nov 19, 2013
RecallFDA
Ultradent Products, Inc.
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic tr...
Medical Devices·217 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or flu...
Medical Devices·7,274 affected·Nov 19, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Varian Medical Systems, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuit...
Medical Devices·6,701 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxima...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proxim...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designe...
Medical Devices·34 affected·Nov 18, 2013
High RiskFDA
Cmp Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number...
Medical Devices·246 affected·Nov 18, 2013
High RiskFDA
Medtronic Neurosurgery
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog ...
Medical Devices·288 affected·Nov 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Medical Devices·147 affected·Nov 15, 2013
High RiskFDA
Smith & Nephew Inc.
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Medical Devices·6,871,375 affected·Nov 14, 2013
High RiskFDA
Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with li...
Medical Devices·390 affected·Nov 12, 2013
High RiskFDA
Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with lim...
Medical Devices·265 affected·Nov 12, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize...
Medical Devices·4,381 affected·Nov 11, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize he...
Medical Devices·4,381 affected·Nov 11, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Medical Devices·768 affected·Nov 8, 2013
High RiskFDA
Biomerieux France Chemin De L'or
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella...
Medical Devices·39,439 affected·Nov 8, 2013
High RiskFDA
Carefusion 303, Inc.
VersaSafe Extension Set, Model No. 21000M-007
Medical Devices·3,500 affected·Nov 8, 2013
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation...
Medical Devices·40 affected·Nov 7, 2013
High RiskFDA
Eos Imaging
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Medical Devices·22 affected·Nov 7, 2013
High RiskFDA
Boston Scientific Corporation
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in...
Medical Devices·449 affected·Nov 5, 2013
High RiskFDA
Asi Medical, Inc.
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in ...
Medical Devices·337 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
NGK Stem Ext 24 x 245mm
Medical Devices·42 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
DIST LAT FEM LOCK PLT, RT
Medical Devices·42 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
FEM COND BUTTRESS PLT, LT
Medical Devices·42 affected·Nov 5, 2013
High RiskFDA
Zimmer, Inc.
Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monom...
Medical Devices·1,534 affected·Nov 4, 2013