Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fro...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from ...
Medical Devices·113 affected·Aug 14, 2015
High RiskFDA
Revmedx Inc
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual co...
Medical Devices·5,004 affected·Aug 12, 2015
High RiskFDA
Ge Healthcare
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communicat...
Medical Devices·26 affected·Aug 11, 2015
High RiskFDA
Alcon Research, Ltd.
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an ac...
Medical Devices·688 affected·Aug 11, 2015
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and commu...
Medical Devices·82 affected·Aug 11, 2015
High RiskFDA
Covidien Llc
Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushin...
Medical Devices·207,876 affected·Aug 6, 2015
High RiskFDA
Trilliant Surgical Ltd.
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-ST...
Medical Devices·28 affected·Aug 6, 2015
High RiskFDA
Villa Radiology Systems Llc
Owandy Radiology I -MAX Touch 3D X-ray
Medical Devices·3 affected·Aug 5, 2015
High RiskFDA
Villa Radiology Systems Llc
Villa Sistemi Rotograph EVO 3D X-ray
Medical Devices·3 affected·Aug 5, 2015
High RiskFDA
Biomet Spine, Llc
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Medical Devices·7 affected·Aug 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of ca...
Medical Devices·26 affected·Aug 5, 2015
High RiskFDA
Bayer Healthcare
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically fo...
Medical Devices·71 affected·Aug 4, 2015
High RiskFDA
Ferno-washington Inc
Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport.
Medical Devices·72 affected·Aug 3, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Covidien Llc
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of hea...
Medical Devices·164 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Covidien Llc
Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat ...
Medical Devices·68,800 affected·Jul 31, 2015
High RiskFDA
Trilliant Surgical Ltd.
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Pl...
Medical Devices·108 affected·Jul 31, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT)...
Medical Devices·185 affected·Jul 31, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment f...
Medical Devices·5,306,080 affected·Jul 29, 2015
High RiskFDA
Bd Life Sciences
Software version 4.44A utilized on the BD MAX System
Medical Devices·29 affected·Jul 29, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are sy...
Medical Devices·1,113 affected·Jul 29, 2015
High RiskFDA
Orthopediatrics Corp
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. ...
Medical Devices·5 affected·Jul 28, 2015
High RiskFDA
Sunrise Medical (us) Llc
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide ...
Medical Devices·64 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
Medical Devices·35 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Medical Devices·4 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Medical Devices·8 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·1 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·5 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
Medical Devices·6 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Medical Devices·2 affected·Jul 27, 2015
High RiskFDA
Transonic Systems Inc
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Medical Devices·6 affected·Jul 27, 2015
High RiskFDA
Sunrise Medical (us) Llc
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provid...
Medical Devices·64 affected·Jul 27, 2015
High RiskFDA
Lifeline Systems, Incorporated
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
Medical Devices·8,616 affected·Jul 23, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum followi...
Medical Devices·451 affected·Jul 22, 2015
High RiskFDA
Wright Medical Technology, Inc.
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3...
Medical Devices·5,687 affected·Jul 21, 2015
High RiskFDA
Wright Medical Technology, Inc.
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0...
Medical Devices·107 affected·Jul 21, 2015
CriticalFDA
Carefusion 303, Inc.
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226...
Medical Devices·68,460 affected·Jul 21, 2015
High RiskFDA
Trilliant Surgical Ltd.
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm;...
Medical Devices·638 affected·Jul 20, 2015
High RiskFDA
Elcam Medical, Inc.
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elc...
Medical Devices·248,100 affected·Jul 19, 2015
High RiskFDA
Elcam Medical, Inc.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administrat...
Medical Devices·7,721,580 affected·Jul 19, 2015
RecallFDA
Microbiologics Inc
LYFO Disk
Medical Devices·3 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
Lightspeed 16 CT
Medical Devices·416 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
PET Discovery LS
Medical Devices·6 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
PET Discovery ST 16
Medical Devices·18 affected·Jul 17, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needl...
Medical Devices·1,415 affected·Jul 17, 2015