Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets an...
Medical Devices·47 affected·Oct 6, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindr...
Medical Devices·455 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part cove...
Medical Devices·5 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for th...
Medical Devices·0 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Medical Devices·1 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the ...
Medical Devices·15 affected·Oct 6, 2014
High RiskFDA
Mwt Materials, Inc.
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the M...
Medical Devices·18 affected·Oct 6, 2014
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KW...
Medical Devices·1,873 affected·Oct 6, 2014
High RiskFDA
Monteris Medical Corp
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the Neur...
Medical Devices·133 affected·Oct 3, 2014
High RiskFDA
Monteris Medical Corp
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroB...
Medical Devices·234 affected·Oct 3, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT;...
Medical Devices·7,587 affected·Oct 3, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Medical Devices·11 affected·Oct 2, 2014
High RiskFDA
Medartis, Inc.
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular...
Medical Devices·44 affected·Oct 1, 2014
High RiskFDA
Boston Scientific Corporation
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Medical Devices·7 affected·Sep 30, 2014
High RiskFDA
Coloplast Manufacturing Us, Llc
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Medical Devices·217,540 affected·Sep 29, 2014
High RiskFDA
Smiths Medical Asd, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication ...
Medical Devices·24 affected·Sep 29, 2014
High RiskFDA
Dharma Research, Inc.
Dharma Cavity Varnish 15mL
Medical Devices·916 affected·Sep 29, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Saturated Gauze Dressing Wound management
Medical Devices·21,108 affected·Sep 26, 2014
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The...
Medical Devices·12 affected·Sep 26, 2014
High RiskFDA
Tecan Us, Inc.
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It ...
Medical Devices·2 affected·Sep 26, 2014
High RiskFDA
Iba Dosimetry Gmbh
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Medical Devices·124 affected·Sep 25, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module
Medical Devices·68,452 affected·Sep 19, 2014
High RiskFDA
Kci Usa, Inc.
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technol...
Medical Devices·1,090 affected·Sep 18, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagn...
Medical Devices·3 affected·Sep 18, 2014
High RiskFDA
Biomerica
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Medical Devices·1,062 affected·Sep 18, 2014
CriticalFDA
Covidien Llc
MediChoice¿ Multifunction Electrode Part Number: MC171 OH
Medical Devices·330 affected·Sep 18, 2014
High RiskFDA
Nordicneurolab As
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties an...
Medical Devices·22 affected·Sep 17, 2014
CriticalFDA
Richard-allan Scientific Company
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histol...
Medical Devices·235 affected·Sep 17, 2014
CriticalFDA
Richard-allan Scientific Company
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing a...
Medical Devices·285 affected·Sep 17, 2014
High RiskFDA
Invivo Corporation
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Ex...
Medical Devices·639 affected·Sep 14, 2014
High RiskFDA
Eyemart Express Ltd
Prescription eyeglass safety lenses. Vision correction
Medical Devices·76 affected·Sep 12, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectiona...
Medical Devices·79 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 ...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunog...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human ...
Medical Devices·0 affected·Sep 11, 2014
High RiskFDA
Intertrade Imports Inc.
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, ...
Medical Devices·750 affected·Sep 10, 2014
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
Medical Devices·16,380 affected·Sep 9, 2014
High RiskFDA
Instrumed International, Inc.
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und...
Medical Devices·3 affected·Sep 8, 2014
CriticalFDA
Teleflex Medical
Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a p...
Medical Devices·27,176 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold un...
Medical Devices·13 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fra...
Medical Devices·2 affected·Sep 8, 2014
High RiskFDA
Instrumed International, Inc.
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under...
Medical Devices·5 affected·Sep 8, 2014
High RiskFDA
Teleflex Medical
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauap...
Medical Devices·3,193,548 affected·Sep 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the sur...
Medical Devices·875 affected·Sep 3, 2014
High RiskFDA
Teleflex Medical
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, S...
Medical Devices·3,193,548 affected·Sep 3, 2014
High RiskFDA
Baxter Healthcare Corp.
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Medical Devices·56 affected·Sep 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscop...
Medical Devices·5 affected·Sep 2, 2014
High RiskFDA
Synthes, Inc.
DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm ...
Medical Devices·16 affected·Sep 2, 2014