Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, ...
Medical Devices·19 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V...
Medical Devices·85 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204H...
Medical Devices·169 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 18093...
Medical Devices·32 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 10010...
Medical Devices·5,777 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206H...
Medical Devices·780 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, ...
Medical Devices·409 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315V...
Medical Devices·666 affected·Nov 22, 2019
High RiskFDA
Elekta Inc
Monaco Radiation Treatment Planning System (RTP) System
Medical Devices·76 affected·Nov 22, 2019
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained ...
Medical Devices·1,233 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version ...
Medical Devices·0 affected·Nov 21, 2019
High RiskFDA
Deroyal Industries Inc
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
Medical Devices·2,789 affected·Nov 21, 2019
High RiskFDA
Stryker Gmbh
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product...
Medical Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-...
Medical Devices·0 affected·Nov 21, 2019
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by train...
Medical Devices·544 affected·Nov 21, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490425
Medical Devices·2,736 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490293
Medical Devices·1,050 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490530
Medical Devices·9,000 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Medical Devices·5,616 affected·Nov 20, 2019
High RiskFDA
B. Braun Medical, Inc.
Safeline Y-Type Blood Set, Catalog Number V2500
Medical Devices·19,500 affected·Nov 20, 2019
High RiskFDA
Angiodynamics, Inc.
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are i...
Medical Devices·160 affected·Nov 19, 2019
High RiskFDA
Angiodynamics, Inc.
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during ...
Medical Devices·4 affected·Nov 19, 2019
High RiskFDA
Angiodynamics, Inc.
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to meas...
Medical Devices·60 affected·Nov 19, 2019
High RiskFDA
Viewray, Inc.
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS)...
Medical Devices·32 affected·Nov 18, 2019
High RiskFDA
Raysearch Laboratories Ab
RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 ...
Medical Devices·956 affected·Nov 18, 2019
RecallFDA
Livanova Usa Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Medical Devices·140 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·139 affected·Nov 18, 2019
High RiskFDA
Boston Scientific Corporation
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and a...
Medical Devices·179 affected·Nov 18, 2019
High RiskFDA
Diagnostica Stago, Inc.
STA SYSTEM CONROL N + P (ref. 00678)
Medical Devices·5,437 affected·Nov 18, 2019
CriticalFDA
Tytek Medical Inc
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the remov...
Medical Devices·3,565 affected·Nov 15, 2019
High RiskFDA
Baxter Healthcare Corporation
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Medical Devices·101,976 affected·Nov 15, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Medical Devices·3 affected·Nov 14, 2019
High RiskFDA
Linet Spol. S.r.o.
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product U...
Medical Devices·518 affected·Nov 13, 2019
High RiskFDA
Medtronic Xomed, Inc.
Lamicel 10PK 10MM INTL
Medical Devices·10 affected·Nov 13, 2019
High RiskFDA
Ge Healthcare, Llc
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed hea...
Medical Devices·11,347 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and ...
Medical Devices·41,848 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data with...
Medical Devices·10,661 affected·Nov 12, 2019
High RiskFDA
Medicrea International
Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Medical Devices·3 affected·Nov 11, 2019
High RiskFDA
Nextremity Solutions
Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
Medical Devices·86 affected·Nov 11, 2019
High RiskFDA
Nextremity Solutions
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Medical Devices·87 affected·Nov 11, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Medical Devices·83 affected·Nov 7, 2019
High RiskFDA
Ethicon Endo-surgery Inc
Ligamax 5 mm Endoscopic Multiple Clip Applier
Medical Devices·48,428 affected·Nov 7, 2019
High RiskFDA
Neuronetrix Solutions, Llc Dba Cognision
Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with exter...
Medical Devices·3,108 affected·Nov 7, 2019
High RiskFDA
Avanos Medical, Inc.
Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201...
Medical Devices·114,300 affected·Nov 5, 2019
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Healix Knotless ADV BR 4.75 Suture Anchor
Medical Devices·299 affected·Nov 4, 2019
High RiskFDA
Trilliant Surgical, Llc
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Medical Devices·117 affected·Nov 4, 2019
High RiskFDA
Villa Sistemi Medicali S.p.a.
Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluorosco...
Medical Devices·46 affected·Nov 4, 2019
High RiskFDA
Villa Sistemi Medicali S.p.a.
Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform ...
Medical Devices·1 affected·Nov 4, 2019