Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Medical Devices·38 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
Medical Devices·32 affected·Mar 9, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T...
Medical Devices·9,369 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal re...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x10mm, Article No. 36700.
Medical Devices·1,456 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Medical Devices·23 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Medical Devices·2 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x8mm, Article No. 36704.
Medical Devices·102 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x13mm, Article No. 36702.
Medical Devices·594 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the sk...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Medical Devices·1,155 affected·Mar 9, 2015
High RiskFDA
Ge Healthcare
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Medical Devices·797 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occ...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Specialty Appliance Works, Inc.
HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used ...
Medical Devices·14,428 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Medical Devices·53 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x10mm, Article No. 36705.
Medical Devices·1,077 affected·Mar 9, 2015
High RiskFDA
Bacterin International, Inc.
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in th...
Medical Devices·63 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x10mm, Article No. 36711.
Medical Devices·636 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Medical Devices·679 affected·Mar 9, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
Medical Devices·167 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
Medical Devices·102 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
Medical Devices·172 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
Medical Devices·138 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
Medical Devices·301 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
Medical Devices·52 affected·Mar 6, 2015
High RiskFDA
Brainlab Ag
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for st...
Medical Devices·25 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Medical Devices·100 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
Medical Devices·372 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
Medical Devices·92 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
Medical Devices·102 affected·Mar 6, 2015
High RiskFDA
Nidek Inc
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by m...
Medical Devices·799 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
Medical Devices·148 affected·Mar 6, 2015
High RiskFDA
Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Medical Devices·13 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
Medical Devices·270 affected·Mar 6, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Direct Water feed Kit, Catalog#10373222
Medical Devices·15 affected·Mar 5, 2015
High RiskFDA
Sony Latin America
Sony Medical Monitor LMD-1951MD 19 inch
Medical Devices·4,764 affected·Mar 5, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge LIS software.
Medical Devices·413 affected·Mar 5, 2015
High RiskFDA
Raysearch Laboratories Ab
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RaySta...
Medical Devices·245 affected·Mar 4, 2015
High RiskFDA
Hill-rom, Inc.
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Medical Devices·66,691 affected·Mar 2, 2015
High RiskFDA
Baxter Healthcare Corp
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Prod...
Medical Devices·58 affected·Mar 2, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial ...
Medical Devices·4 affected·Feb 27, 2015
High RiskFDA
Quest Medical, Inc.
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Medical Devices·106 affected·Feb 26, 2015
High RiskFDA
Captiva Spine, Inc
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Medical Devices·233 affected·Feb 25, 2015
RecallFDA
Biomerieux Inc
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 System...
Medical Devices·2,053 affected·Feb 25, 2015
RecallFDA
Biomerieux Inc
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 System...
Medical Devices·10,409 affected·Feb 25, 2015
High RiskFDA
Synthes, Inc.
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANC...
Medical Devices·131 affected·Feb 24, 2015
High RiskFDA
Abbott Medical Optics, Inc.
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use ...
Medical Devices·202 affected·Feb 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std...
Medical Devices·133,751 affected·Feb 20, 2015