Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Synergetics Inc
"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. M...
Medical Devices·12 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, In...
Medical Devices·36 affected·Dec 9, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP...
Medical Devices·7 affected·Dec 9, 2013
High RiskFDA
Synergetics Inc
25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergeti...
Medical Devices·6 affected·Dec 9, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConn...
Medical Devices·5 affected·Dec 6, 2013
High RiskFDA
Rti Surgical, Inc.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using...
Medical Devices·14 affected·Dec 6, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Medical Devices·19 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Medical Devices·47 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray syste...
Medical Devices·424 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Medical Devices·255 affected·Dec 4, 2013
High RiskFDA
The Anspach Effort, Inc.
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cuttin...
Medical Devices·150 affected·Dec 3, 2013
High RiskFDA
Medx Holdings, Inc.
Cervical Extension Machine for Physical Therapy
Medical Devices·4 affected·Dec 3, 2013
RecallFDA
Microgenics Corporation
MAS Omni Immune PRO Controls
Medical Devices·1,393 affected·Dec 2, 2013
High RiskFDA
Eos Imaging
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstati...
Medical Devices·36 affected·Nov 29, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Medical Devices·178,711 affected·Nov 27, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the ST...
Medical Devices·4,048 affected·Nov 26, 2013
High RiskFDA
Becton Dickinson & Company
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ inje...
Medical Devices·268,500 affected·Nov 26, 2013
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is desig...
Medical Devices·108,769 affected·Nov 26, 2013
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subar...
Medical Devices·731 affected·Nov 26, 2013
High RiskFDA
Stryker Medical Division Of Stryker Corporation
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for...
Medical Devices·108,769 affected·Nov 26, 2013
High RiskFDA
Biomet, Inc.
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Medical Devices·532 affected·Nov 26, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·300 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or...
Medical Devices·13 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined tar...
Medical Devices·1,309 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Medical Devices·455 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has be...
Medical Devices·1,424 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for th...
Medical Devices·489 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determine...
Medical Devices·312 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·134 affected·Nov 25, 2013
High RiskFDA
Abbott Vascular, Inc.
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 19...
Medical Devices·54,895 affected·Nov 25, 2013
High RiskFDA
Smith & Nephew Inc
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, In...
Medical Devices·38 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very fre...
Medical Devices·1,028 affected·Nov 25, 2013
High RiskFDA
Abbott Molecular
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Medical Devices·176 affected·Nov 23, 2013
High RiskFDA
Ziehm Imaging Inc
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Medical Devices·54 affected·Nov 21, 2013
High RiskFDA
3m Company - Health Care Business
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are i...
Medical Devices·1,977 affected·Nov 21, 2013
High RiskFDA
Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Ste...
Medical Devices·6,028 affected·Nov 21, 2013
High RiskFDA
Ziehm Imaging Inc
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Medical Devices·83 affected·Nov 21, 2013
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision ...
Medical Devices·698 affected·Nov 21, 2013
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack...
Medical Devices·45 affected·Nov 21, 2013
High RiskFDA
Ziehm Imaging Inc
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Medical Devices·58 affected·Nov 21, 2013
High RiskFDA
Neuro Kinetics, Inc.
Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (...
Medical Devices·148 affected·Nov 21, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Bosto...
Medical Devices·253 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserte...
Medical Devices·25 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device...
Medical Devices·3,300 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Bosto...
Medical Devices·425 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·922 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Bost...
Medical Devices·0 affected·Nov 20, 2013