Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Koojoo Trading Company
Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing d...
Medical Devices·7 affected·Jul 3, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY...
Medical Devices·12,546 affected·Jul 2, 2013
High RiskFDA
Elekta, Inc.
Monaco RTP System Radiation treatment planning
Medical Devices·45 affected·Jul 2, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for ...
Medical Devices·10,537 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medic...
Medical Devices·1,800 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek M...
Medical Devices·6,040 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care R...
Medical Devices·6,000 affected·Jul 2, 2013
High RiskFDA
Ecolab Inc
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Mi...
Medical Devices·2,102 affected·Jul 2, 2013
High RiskFDA
Zimmer, Inc.
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Ins...
Medical Devices·3,163 affected·Jun 28, 2013
High RiskFDA
Insight Instruments, Inc.
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full fiel...
Medical Devices·10,212 affected·Jun 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the prin...
Medical Devices·950 affected·Jun 26, 2013
High RiskFDA
Mar Cor Purification
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is i...
Medical Devices·232 affected·Jun 26, 2013
RecallFDA
Convatec Inc.
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-l...
Medical Devices·22,896 affected·Jun 25, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer...
Medical Devices·5 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-s...
Medical Devices·448 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sens...
Medical Devices·331 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensi...
Medical Devices·37 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible...
Medical Devices·100 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensit...
Medical Devices·308 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible p...
Medical Devices·660 affected·Jun 21, 2013
High RiskFDA
Picis Inc.
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a d...
Medical Devices·35 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-s...
Medical Devices·110 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polyme...
Medical Devices·45 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-...
Medical Devices·220 affected·Jun 21, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of pla...
Medical Devices·13 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-...
Medical Devices·100 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensi...
Medical Devices·652 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible...
Medical Devices·181 affected·Jun 21, 2013
High RiskFDA
Haemonetics Corporation
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Medical Devices·1,590 affected·Jun 20, 2013
RecallFDA
Technidata S.a.
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Info...
Medical Devices·1 affected·Jun 20, 2013
RecallFDA
Beekley Corporation
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Medical Devices·81 affected·Jun 19, 2013
High RiskFDA
Carestream Health Inc.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The...
Medical Devices·331 affected·Jun 19, 2013
High RiskFDA
Invacare Corporation
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in pers...
Medical Devices·285 affected·Jun 18, 2013
High RiskFDA
Hospira Inc.
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NO...
Medical Devices·14,400 affected·Jun 18, 2013
CriticalFDA
Lemaitre Vascular, Inc.
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material an...
Medical Devices·7 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices·3 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices·2 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and desi...
Medical Devices·2 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and de...
Medical Devices·1 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices·1 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices·3 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and...
Medical Devices·3 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and de...
Medical Devices·2 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and de...
Medical Devices·3 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and...
Medical Devices·3 affected·Jun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and...
Medical Devices·1 affected·Jun 17, 2013
High RiskFDA
Pioneer Surgical Technology, Inc.
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for...
Medical Devices·9 affected·Jun 14, 2013
CriticalFDA
Ge Healthcare, Llc
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for dete...
Medical Devices·25 affected·Jun 13, 2013