FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02
FDA Device · Class II · 2015-05-13 · Spacelabs Healthcare - 1/8 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Ad…
FDA Device · Class II · 2015-05-13 · Icu Medical - ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ster…
FDA Device · Class II · 2015-05-13 · Brainlab Ag - 1/4 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP…
FDA Device · Class II · 2015-05-13 · Icu Medical - EOS, Digital radiography system used in general radiographic examinations
FDA Device · Class II · 2015-05-13 · Eos Imaging - 1/8 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administra…
FDA Device · Class II · 2015-05-13 · Icu Medical - ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816
FDA Device · Class II · 2015-05-13 · Siemens Medical Solutions Usa - CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom…
FDA Device · Class II · 2015-05-13 · B Braun Medical - BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single p…
FDA Device · Class II · 2015-05-13 · Bard Peripheral Vascular - AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation
FDA Device · Class II · 2015-05-06 · Steris - Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only
FDA Device · Class II · 2015-05-06 · Teleflex Medical - AmTryke Model 1424 Community Cruiser Hand Cycle
FDA Device · Class II · 2015-05-06 · Amtryke - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure
FDA Device · Class II · 2015-05-06 · Biosense Webster - 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada
FDA Device · Class II · 2015-05-06 · Fresenius Medical Care Holdings - PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the admini…
FDA Device · Class II · 2015-05-06 · Bard Access Systems - CareFusion Vital Signs LightWand Stylet
FDA Device · Class II · 2015-05-06 · Vital Signs Colorado - 9F Plastic Dual Port
FDA Device · Class II · 2015-05-06 · Medical Components - 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC)
FDA Device · Class II · 2015-05-06 · Fresenius Medical Care Holdings - Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Ther…
FDA Device · Class II · 2015-05-06 · Therasage - Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITRO…
FDA Device · Class II · 2015-05-06 · Ortho Clinical Diagnostics - Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder
FDA Device · Class II · 2015-05-06 · Zimmer - GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
FDA Device · Class II · 2015-05-06 · Ge Healthcare - CD99 Catalog number PM008 AA
FDA Device · Class II · 2015-05-06 · Biocare Medical - FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health,…
FDA Device · Class II · 2015-05-06 · Therasage - FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health,…
FDA Device · Class II · 2015-05-06 · Therasage - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and gener…
FDA Device · Class II · 2015-05-06 · Steris - MicroScan -Neg Breakpoint Combo Panel Type 34
FDA Device · Class II · 2015-05-06 · Beckman Coulter - GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA Device · Class II · 2015-05-06 · Ge Healthcare - Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery
FDA Device · Class II · 2015-05-06 · The Anspach Effort - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX
FDA Device · Class II · 2015-05-06 · Fresenius Medical Care Holdings - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalog…
FDA Device · Class II · 2015-05-06 · Integra Lifesciences D B A Integra Pain Management - MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determin…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250
FDA Device · Class II · 2015-05-06 · Coloplast Manufacturing Us - VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104
FDA Device · Class II · 2015-05-06 · Cyberonics - Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option
FDA Device · Class II · 2015-05-06 · Spacelabs Healthcare - Light Sheer Desire Diode Laser System with XC Handpiece Accessory options
FDA Device · Class II · 2015-05-06 · Lumenis - Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro di…
FDA Device · Class II · 2015-05-06 · Dako North America - Introduction Pack
FDA Device · Class II · 2015-05-06 · Vital Signs Colorado - 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE
FDA Device · Class II · 2015-05-06 · Fresenius Medical Care Holdings - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic ass…
FDA Device · Class II · 2015-05-06 · Ga Industries - 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Platin…
FDA Device · Class II · 2015-05-06 · Alphatec Spine - Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40
FDA Device · Class II · 2015-05-06 · Nihon Kohden America - Insorb Subcuticular Skin Stapler
FDA Device · Class II · 2015-05-06 · Incisive Surgical - GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
FDA Device · Class II · 2015-05-06 · Ge Healthcare - The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus…
FDA Device · Class II · 2015-05-06 · Baxter Healthcare - MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakp…
FDA Device · Class II · 2015-05-06 · Beckman Coulter - Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System
FDA Device · Class II · 2015-05-06 · Pega Medical - CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an…
FDA Device · Class II · 2015-04-29 · Biomet Spine - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed l…
FDA Device · Class II · 2015-04-29 · Hospira - CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - OptiMedica Catalys Precision Laser System
FDA Device · Class II · 2015-04-29 · Abbott Medical Optics - DBX Mix, 20 cc, Product Code: 058200
FDA Device · Class II · 2015-04-29 · Musculoskeletal Transplant Foundation - CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect changes in the skeleta…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique
FDA Device · Class II · 2015-04-29 · Spinefrontier - CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or o…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skele…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00
FDA Device · Class II · 2015-04-29 · Del Mar Reynolds Medical - CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - 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 relat…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894
FDA Device · Class II · 2015-04-29 · Siemens Healthcare Diagnostics - Fluid Management System P4000
FDA Device · Class II · 2015-04-29 · Thermedx - 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 to…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical flui…
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - STRATIFY JCV DxSelect, Model No. EL1950
FDA Device · Class II · 2015-04-29 · Focus Diagnostics - TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ost…
FDA Device · Class I · 2015-04-29 · Laax - TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk),…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical
FDA Device · Class I · 2015-04-29 · Origen Biomedical - CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Compon…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ost…
FDA Device · Class I · 2015-04-29 · Laax - CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and prot…
FDA Device · Class II · 2015-04-29 · Photomedex - Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
FDA Device · Class II · 2015-04-29 · Churchill Medical Systems - Specialty MiniScope Mech
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use
FDA Device · Class II · 2015-04-29 · Wright Medical Technology - Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skele…
FDA Device · Class II · 2015-04-29 · Specialty Appliance Works - Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers)
FDA Device · Class II · 2015-04-29 · Captiva Spine - Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland
FDA Device · Class II · 2015-04-29 · Sentec Ag - Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upp…
FDA Device · Class II · 2015-04-29 · Biomet Spine
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