Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment...
Medical Devices·229 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 ...
Medical Devices·2 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Respos...
Medical Devices·259 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122...
Medical Devices·907 affected·May 3, 2013
High RiskFDA
Surgical Instrument Service And Savings, Inc.
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Fla...
Medical Devices·90 affected·May 3, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Medical Devices·445 affected·May 2, 2013
High RiskFDA
Applied Medical Resources Corp
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tiss...
Medical Devices·127,305 affected·May 1, 2013
High RiskFDA
Becton Dickinson & Company
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Medical Devices·1,326,000 affected·May 1, 2013
High RiskFDA
Elekta, Inc.
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometric...
Medical Devices·35 affected·May 1, 2013
High RiskFDA
Angiodynamics, Inc.
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog N...
Medical Devices·1,760 affected·Apr 30, 2013
High RiskFDA
Hill-rom, Inc.
SlingBar 350. Designed to meet the needs for lifting humans.
Medical Devices·3,556 affected·Apr 30, 2013
High RiskFDA
Hill-rom, Inc.
SlingBar Standard. Designed to meet the needs for lifting humans.
Medical Devices·726 affected·Apr 30, 2013
High RiskFDA
Elekta, Inc.
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conform...
Medical Devices·31 affected·Apr 30, 2013
High RiskFDA
Beckman Coulter Inc.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body flui...
Medical Devices·108 affected·Apr 26, 2013
High RiskFDA
Biomet, Inc.
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Medical Devices·8 affected·Apr 26, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and...
Medical Devices·12 affected·Apr 25, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Medical Devices·976 affected·Apr 25, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gam...
Medical Devices·505 affected·Apr 25, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
Medical Devices·2,785 affected·Apr 25, 2013
High RiskFDA
Instratek, Incorporated
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Medical Devices·96 affected·Apr 25, 2013
CriticalFDA
Brainlab Ag
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS Sys...
Medical Devices·2,528 affected·Apr 22, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standar...
Medical Devices·69,994 affected·Apr 22, 2013
High RiskFDA
Orthopediatrics Corp
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate Syste...
Medical Devices·130 affected·Apr 19, 2013
High RiskFDA
Orthopediatrics Corp
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate Syste...
Medical Devices·130 affected·Apr 19, 2013
High RiskFDA
Depuy Spine, Inc.
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous deli...
Medical Devices·3,896 affected·Apr 17, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body...
Medical Devices·2,348 affected·Apr 15, 2013
High RiskFDA
Medrad Inc
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Medical Devices·1,066 affected·Apr 15, 2013
High RiskFDA
Varian Medical Systems, Inc.
Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed...
Medical Devices·21 affected·Apr 11, 2013
High RiskFDA
Symmetry Medical/ssi
Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum ret...
Medical Devices·524 affected·Apr 10, 2013
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The fi...
Medical Devices·80 affected·Apr 9, 2013
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The f...
Medical Devices·10 affected·Apr 9, 2013
High RiskFDA
Alpine Biomed Aps
Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A...
Medical Devices·871 affected·Apr 9, 2013
RecallFDA
National Biological Corp
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiat...
Medical Devices·124 affected·Apr 9, 2013
High RiskFDA
Medtox Diagnostics Inc
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
Medical Devices·221,625 affected·Apr 5, 2013
High RiskFDA
B. Braun Medical, Inc.
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer bet...
Medical Devices·1,746,079 affected·Apr 4, 2013
High RiskFDA
Medshape Solutions, Inc.
ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to b...
Medical Devices·26 affected·Apr 4, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ...
Medical Devices·245 affected·Apr 4, 2013
High RiskFDA
Intel-ge Care Innovations Llc
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housi...
Medical Devices·1,722 affected·Apr 4, 2013
High RiskFDA
Leica Microsystems, Inc.
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; ...
Medical Devices·20,160 affected·Apr 4, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter ...
Medical Devices·28,120 affected·Apr 3, 2013
High RiskFDA
Ge Healthcare, Llc
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The P...
Medical Devices·16,462 affected·Apr 3, 2013
CriticalFDA
Hospira Inc.
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiri...
Medical Devices·1,152 affected·Apr 1, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc. Dba Renal Solutions
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hem...
Medical Devices·132 affected·Apr 1, 2013
CriticalFDA
Hospira Inc.
List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration...
Medical Devices·692,742 affected·Apr 1, 2013
CriticalFDA
Hospira Inc.
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inc...
Medical Devices·96 affected·Apr 1, 2013
CriticalFDA
Hospira Inc.
List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood P...
Medical Devices·1,976 affected·Apr 1, 2013
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Medical Devices·425 affected·Apr 1, 2013
High RiskFDA
Integra Lifesciences Corporation
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended...
Medical Devices·31,940 affected·Mar 28, 2013