Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Life Force Of Tampa, Llc
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Medical Devices·10 affected·Jun 27, 2014
High RiskFDA
Hill-rom, Inc.
Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR...
Medical Devices·13,000 affected·Jun 26, 2014
High RiskFDA
Biosound Esaote, Inc.
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Medical Devices·1,301 affected·Jun 26, 2014
High RiskFDA
Alphatec Spine, Inc.
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation...
Medical Devices·14 affected·Jun 26, 2014
High RiskFDA
Invacare Corporation
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Medical Devices·465 affected·Jun 25, 2014
High RiskFDA
Biomet 3i, Llc
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaini...
Medical Devices·6 affected·Jun 25, 2014
High RiskFDA
Mckesson Information Solutions Llc
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acqui...
Medical Devices·625 affected·Jun 25, 2014
High RiskFDA
Invacare Corporation
MK5 NX Controller--Wheelchair controller
Medical Devices·819 affected·Jun 24, 2014
High RiskFDA
Stryker Endoscopy
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, u...
Medical Devices·496 affected·Jun 20, 2014
High RiskFDA
Origio, Inc
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
Medical Devices·32,760 affected·Jun 20, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Medical Devices·585,360 affected·Jun 17, 2014
High RiskFDA
Varian Medical Systems, Inc.
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21E...
Medical Devices·3,416 affected·Jun 17, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Medical Devices·1,713 affected·Jun 17, 2014
High RiskFDA
Nidek Inc
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of ...
Medical Devices·185 affected·Jun 16, 2014
High RiskFDA
Mckesson Technologies, Inc.
Paragon Laboratory Management
Medical Devices·128 affected·Jun 15, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 3.0T, magnetic resonance imaging system.
Medical Devices·18 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 3.0T R5, magnetic resonance imaging system.
Medical Devices·21 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 1.5T, magnetic resonance imaging system.
Medical Devices·24 affected·Jun 13, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Medical Devices·41,992 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 1.5T R5, magnetic resonance imaging system.
Medical Devices·33 affected·Jun 13, 2014
High RiskFDA
Biolase Technology Inc
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Medical Devices·117 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
High RiskFDA
Medical Action Industries Inc
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Medical Devices·474 affected·Jun 12, 2014
CriticalFDA
Ge Healthcare, Llc
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N...
Medical Devices·2,948 affected·Jun 11, 2014
High RiskFDA
Baxter Healthcare Corp.
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXA...
Medical Devices·1,758 affected·Jun 10, 2014
High RiskFDA
Arjohuntleigh Polska Sp. Zo.o.
Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other ...
Medical Devices·382 affected·Jun 10, 2014
CriticalFDA
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and m...
Medical Devices·5,744 affected·Jun 9, 2014
High RiskFDA
3m Company - Health Care Business
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a po...
Medical Devices·5,343 affected·Jun 9, 2014
High RiskFDA
Integra Lifesciences Corp.
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm)...
Medical Devices·94 affected·Jun 9, 2014
High RiskFDA
Hospira Inc.
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended...
Medical Devices·13 affected·Jun 6, 2014
High RiskFDA
Becton Dickinson & Co.
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the grow...
Medical Devices·7,617 affected·Jun 6, 2014
High RiskFDA
Becton Dickinson & Co.
Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recove...
Medical Devices·775 affected·Jun 6, 2014
High RiskFDA
Becton Dickinson & Co.
CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or t...
Medical Devices·1,530 affected·Jun 6, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
Medical Devices·206 affected·Jun 5, 2014
High RiskFDA
Pall Corporation
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. ...
Medical Devices·24,650 affected·Jun 4, 2014
High RiskFDA
Deroyal Industries Inc
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries,...
Medical Devices·128 affected·Jun 4, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Medical Devices·2,802 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP (Base), automated coagulation laboratory instrument.
Medical Devices·1,074 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700, automated coagulation laboratory instrument.
Medical Devices·633 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Medical Devices·99 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Medical Devices·266 affected·Jun 3, 2014
High RiskFDA
Alcon Research, Ltd.
eye-pak 7407 Tray Support Cover REF 8065740745
Medical Devices·2,462 affected·Jun 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solution...
Medical Devices·790 affected·Jun 3, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Medical Devices·907 affected·Jun 2, 2014