Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial...
Medical Devices·649 affected·Jul 26, 2012
CriticalFDA
St. Jude Medical
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of c...
Medical Devices·70,638 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer...
Medical Devices·579 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial...
Medical Devices·992 affected·Jul 26, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and ...
Medical Devices·582 affected·Jul 26, 2012
High RiskFDA
Aesculap Implant Systems Llc
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for ...
Medical Devices·5 affected·Jul 25, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an E...
Medical Devices·140 affected·Jul 24, 2012
High RiskFDA
Cisco Systems Inc
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Syste...
Medical Devices·1 affected·Jul 23, 2012
RecallFDA
Trek Diagnostic Systems
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a s...
Medical Devices·333 affected·Jul 23, 2012
High RiskFDA
Nico Corp.
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizab...
Medical Devices·15 affected·Jul 17, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
Medical Devices·126 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (...
Medical Devices·1,213 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isola...
Medical Devices·816 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument syst...
Medical Devices·1,015 affected·Jul 16, 2012
High RiskFDA
Lucero Medical Llc
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thora...
Medical Devices·169 affected·Jul 15, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems...
Medical Devices·270 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automi...
Medical Devices·950 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Sy...
Medical Devices·840 affected·Jul 13, 2012
CriticalFDA
Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix...
Medical Devices·3,106 affected·Jul 13, 2012
CriticalFDA
Medtronic Navigation, Inc.
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027...
Medical Devices·17 affected·Jul 11, 2012
High RiskFDA
Winco Mfg., Llc
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "**...
Medical Devices·23 affected·Jul 10, 2012
High RiskFDA
Ge Healthcare, Llc
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·254 affected·Jul 10, 2012
High RiskFDA
Beekley Corporation
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for mark...
Medical Devices·6,420 affected·Jul 9, 2012
High RiskFDA
Beekley Corporation
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable ma...
Medical Devices·36,518 affected·Jul 9, 2012
High RiskFDA
Beekley Corporation
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable ma...
Medical Devices·32,640 affected·Jul 9, 2012
High RiskFDA
Apheresis Technologies, Inc.
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Medical Devices·13 affected·Jul 9, 2012
High RiskFDA
Fms, Finapres Medical Systems Bv
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be ...
Medical Devices·3 affected·Jul 6, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tamper...
Medical Devices·2 affected·Jul 6, 2012
High RiskFDA
Radiometer America Inc
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Medical Devices·1,427 affected·Jul 5, 2012
High RiskFDA
Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of w...
Medical Devices·6,854 affected·Jul 5, 2012
High RiskFDA
Chicago X-ray Systems, Inc.
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and di...
Medical Devices·1,960 affected·Jul 3, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 3...
Medical Devices·165 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usa...
Medical Devices·4,411 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: ...
Medical Devices·4,661 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product...
Medical Devices·2,204 affected·Jul 3, 2012
High RiskFDA
Greiner Bio-one North America, Inc.
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Inte...
Medical Devices·838 affected·Jul 2, 2012
High RiskFDA
Ethicon, Inc.
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 8...
Medical Devices·4,800 affected·Jul 2, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography ...
Medical Devices·524 affected·Jul 2, 2012
High RiskFDA
Merge Healthcare, Inc.
Merge HEMO software.
Medical Devices·37 affected·Jul 2, 2012
High RiskFDA
Beekley Corporation
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remo...
Medical Devices·86,000 affected·Jul 2, 2012
High RiskFDA
Draeger Medical Systems, Inc.
Drager PT 4000 Phototherapy System
Medical Devices·65 affected·Jul 2, 2012
High RiskFDA
Arjo, Inc. Dba Arjohuntleigh
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, K...
Medical Devices·1,989 affected·Jun 29, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW ap...
Medical Devices·429 affected·Jun 28, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two ...
Medical Devices·159 affected·Jun 27, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two ...
Medical Devices·159 affected·Jun 27, 2012
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 B...
Medical Devices·2,247 affected·Jun 27, 2012
High RiskFDA
Sunrise Medical (us) Llc
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). ...
Medical Devices·14 affected·Jun 26, 2012
CriticalFDA
Ge Healthcare, Llc
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 ...
Medical Devices·209,804 affected·Jun 26, 2012