GE Healthcare, LLC - SIGNA Architect - Class 2 Recall
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Optima MR450w 1.5T - Class 2 Recall
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - SIGNA PET/MR - Class 2 Recall
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery MR750w 3.0T - Class 2 Recall
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - SIGNA Artist - Class 2 Recall
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Encore Medical, LP - EMPOWR Acetabular System - Class 2 Recall
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Dimension Vista Alkaline Phosphatase (ALPI) Flex reagent cartridge - Class 2 Recall
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Yuno II Mobile Operating Table - Class 2 Recall
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Yuno Mobile Operating Table - Class 2 Recall
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Vascular Solutions, Inc. - Langston Dual Lumen Catheter - Class 1 Recall
Langston Dual Lumen Catheter (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Vascular Solutions, Inc. - Langston Dual Lumen Catheter - Class 1 Recall
Langston Dual Lumen Catheter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Invivo Corporation - MR CoilsCoil, magnetic resonance, specialty. - Class 3 Recall
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 21, 2020 Category: Medical Devices Source Type: alerts

Quidel Corporation - Sofia SARS Antigen FIA - Class 2 Recall
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 20, 2020 Category: Medical Devices Source Type: alerts

Becton Dickinson & Company - BD Nexiva Closed IV Catheter System Dual Port - Class 2 Recall
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 20, 2020 Category: Medical Devices Source Type: alerts

Olympus Corporation of the Americas - Olympus CHFCB30S Choledoscope - Class 2 Recall
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - VICRYL MONOFILAMENT VIOLET - Class 2 Recall
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Atellica IM HER2/neu (H2n) assay and calibrator. ADVIA Centaur HER2/neu (H2n) assay and calibrator - Class 2 Recall
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-...
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - GENESIS II CONSTRAINED SYSTEM - Class 2 Recall
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Encore Medical, LP - AltiVate Reverse Small Socket Insert - Class 2 Recall
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Medtronic Vascular - Rashkind Balloon Septostomy Catheter - Class 1 Recall
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Artis Zee and Artis Q systems - Class 2 Recall
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2020 Category: Medical Devices Source Type: alerts

Skytron, Div. The KMW Group, Inc - SkyVision SDS - Class 2 Recall
SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 16, 2020 Category: Medical Devices Source Type: alerts

Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts

BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA - Ezycare Face Masks - Class 2 Recall
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts

Cook Inc. - Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set - Class 2 Recall
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2020 Category: Medical Devices Source Type: alerts

Roche Diagnostics Operations, Inc. - Tinaquant Complement C4 Test System - Class 3 Recall
Tina-quant Complement C4 ver.2, Catalog 05991994190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Roche Diagnostics Operations, Inc. - Roche Diagnostics cobas Integra Albumin Gen.2 - Class 3 Recall
Albumin Gen.2, Catalog 05166861190 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Fresenius Medical Care Holdings, Inc. - AquaBplus and AquaBplus B2 Water Purification System - Class 2 Recall
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Gentian AS - Gentian Cystatin C Immunoassay - Class 2 Recall
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

CooperSurgical, Inc. - MediCult Vitrification Cooling Media - Class 2 Recall
MediCult Vitrification Cooling Media, Model Number 12284001F (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Class 2 Recall
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Class 2 Recall
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 14, 2020 Category: Medical Devices Source Type: alerts

Mizuho OSI - Levo Arm - Class 2 Recall
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Handicare AB - SwiftHook - Class 2 Recall
SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - COMPREHENSIVE REVERSE SHOULDERMINI BASEPLATE - Class 2 Recall
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Getinge Group Logistics America, LLC - Servoi - Class 2 Recall
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - RingLoc BiPolar Hip System Acetabular Cup - Class 2 Recall
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Alcon Research, LLC - Alcon CustomPak Surgical Procedure Packs - Class 2 Recall
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Genicon, Inc. - Aquas PowerFlow Tube Set - Class 2 Recall
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 10, 2020 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - ACUSON AcuNav Volume ICE Catheter - Class 2 Recall
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - Biomet ONPOINT SCOPE PROCEDURE KITEU - Class 2 Recall
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - Regenerex Tibial Components - Class 2 Recall
Biomet Regenerex Primary Taper Cap Item Number 141269 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - Biomet ARTHROSIMPLICITY KIT EU Item Number: 244055 - Class 2 Recall
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet, Inc. - Biomet OnPoint SCOPE PROCEDURE KIT - Class 2 Recall
Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet 3i, LLC - BellaTek Encode - Class 2 Recall
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts

Biomet 3i, LLC - BellaTek Encode - Class 2 Recall
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts