FDA (Device enforcement)

11,102 recalls · page 106 of 112

• Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 402017-11-03
• CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.2017-10-30
• VariCam2017-10-30
• Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.2017-10-23
• HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem nece2017-10-20
• HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO2017-10-20
• The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser ma2017-10-16
• MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.2017-10-14
• Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled 2017-10-11
• VITEK2 GP-ID, REF 21342 IVD2017-10-11
• PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S2017-10-09
• 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.2017-10-05
• Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology mo2017-10-02
• Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-000792017-09-20
• daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or2017-09-19
• 36MM COCR MODULAR HD -6MM2017-09-15
• Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR2017-09-01
• BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.2017-08-29
• Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.2017-08-28
• AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.2017-08-25
• Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. 2017-08-23
• Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.2017-08-22
• Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.2017-08-18
• Coated VICRYL RAPIDETM (Polyglactin 910) Suture2017-08-17
• Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care pr2017-08-11
• Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists o2017-08-09
• Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM2017-08-07
• Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM2017-08-07
• Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM2017-08-07
• Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM2017-08-07
• Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM2017-08-07
• Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM2017-08-07
• Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM2017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L12017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L22017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L12017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L22017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L12017-08-07
• Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L22017-08-07
• Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.2017-08-07
• Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.2017-08-07
• Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.2017-08-07