Voluntis - Insulia Diabetes Management Companion - Class 2 Recall
Insulia Diabetes Management Companion (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2018 Category: Medical Devices Source Type: alerts

The Binding Site Group, Ltd. - Human IgM Kit for use on SPAPLUS - Class 2 Recall
The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2018 Category: Medical Devices Source Type: alerts

Ortho-Clinical Diagnostics - VITROS Chemistry Products dLDL Reagent - Class 2 Recall
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2018 Category: Medical Devices Source Type: alerts

Tosoh Bioscience Inc - AIA2000 Analyzer - Class 2 Recall
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2018 Category: Medical Devices Source Type: alerts

LeMaitre Vascular, Inc. - Class 2 Recall
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2018 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Implantable Cardioverter Defibrillator (NonCRT) - Class 2 Recall
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2018 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista Lipase Flex Reagent Cartridge - Class 2 Recall
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Lipase Flex Reagent Cartridge - Class 2 Recall
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Johnson & Johnson Surgical Vision Inc - Abbott TECNIS iTEC Preloaded Delivery System - Class 2 Recall
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Arrow International Inc - ARROWgard Blue Plus - Class 2 Recall
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Stryker Sustainability Solutions - Reprocessed LASSO NAV eco Electrophysiology Catheter - Class 2 Recall
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Tosoh Bioscience Inc - AIA900 Analyzer - Class 2 Recall
AIA-900 Analyzer, Product code 022930, 022930R (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

Covidien LLC - Parietex Composite Parastomal Mesh - Class 2 Recall
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and...
Source: Medical Device Recalls - November 15, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - GE Healthcare Millennium MG - Class 1 Recall
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - GE Healthcare Millennium MC - Class 1 Recall
GE Healthcare Millennium MC (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - GE Healthcare Millennium MyoSIGHT - Class 1 Recall
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Straumann Manufacturing, Inc. - Endosseous dental implant abutment - Class 2 Recall
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System, - Class 2 Recall
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The Affixus Hip Fracture Nail System - Class 2 Recall
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens ARTIS Zee biplane - Class 2 Recall
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesi...
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens ARTIS Q biplane - Class 2 Recall
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis. (Sour...
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Virtual Imaging, Inc. - RadPRO Mobile 40kW Digital XRay System - Class 2 Recall
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens ARTIS Q.zen - Class 2 Recall
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis. (S...
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

American Contract Systems, Inc. - Powdered Surgical Glvoes - Class 2 Recall
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Invivo Corporation - Xper Flex Cardio Physiomonitoring System - Class 2 Recall
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts

Espiner Medical Ltd - Espiner Tissue Retrieval System - Class 2 Recall
Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2018 Category: Medical Devices Source Type: alerts

BioFire Diagnostics, LLC - BioFire FilmArray Meningitis/Encephalitis (ME) Panel - Class 2 Recall
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2018 Category: Medical Devices Source Type: alerts

Luminex Corporation - The Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP) - Class 2 Recall
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2018 Category: Medical Devices Source Type: alerts

R82 A/S - Heron - Class 2 Recall
Heron toilet and bath chair Model 880505-01 & 880505-11 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

Medtronic Sofamor Danek USA Inc - INFUSE Bone Graft X SMALL KIT - Class 2 Recall
INFUSE Bone Graft X SMALL KIT REF 7510100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

Stryker Medical Division of Stryker Corporation - The Spirit Select Bed, Model 5700 - Class 2 Recall
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

Stryker Medical Division of Stryker Corporation - The Spirit Plus Bed, Model 5600 - Class 2 Recall
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 1S Reinforced BioScaffold 18x22cm - Class 2 Recall
OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 2S Reinforced BioScaffold 18x22cm - Class 2 Recall
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex Reinforced BioScaffold 20x20cm - Class 2 Recall
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex Reinforced BioScaffold 10x20cm - Class 2 Recall
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex Reinforced BioScaffold 16x20cm - Class 2 Recall
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 2S Reinforced BioScaffold 16x20cm - Class 2 Recall
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 2S Reinforced BioScaffold 10x20cm - Class 2 Recall
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 2S Reinforced BioScaffold 10x12cm - Class 2 Recall
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 1S Reinforced BioScaffold 4x8cm - Class 2 Recall
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex Reinforced BioScaffold 10x12cm - Class 2 Recall
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 2S Reinforced BioScaffold 10x12cm - Class 2 Recall
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts

AROA Biosurgery, LTD. - OviTex 1S Reinforced BioScaffold 16x20cm - Class 2 Recall
OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2018 Category: Medical Devices Source Type: alerts