Trilliant Surgical, LLC - Trilliant Surgical Ltd Small Joint Reaming System - Class 2 Recall
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 31, 2020 Category: Medical Devices Source Type: alerts

Stryker Communications - Berchtold Chromophare Ceiling Mounted Surgical Light System - Class 2 Recall
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2020 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Avalon Elite Vascular Access Kit - Class 2 Recall
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT723 Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-723 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT722K Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-722K (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Paradigm Insulin Pump System - Class 2 Recall
MiniMed Paradigm 512 pump (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model 511 Insulin Pump - Class 2 Recall
MiniMed Paradigm 511 pump (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT522K Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-522K (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Veo Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm Veo pump , model numbers MMT-554CM and MMT-754CM (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT723K Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-723K (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT522 Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-522 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT722 Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-722 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Veo Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm Veo Insulin pump , model numbers MMT-554 and MMT-754 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT712E Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-712E (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model numbers MMT 515 and MMT-715 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT523K Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-523K (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Paradigm Insulin Pump System - Class 2 Recall
MiniMed Paradigm pump , model number MMT-712 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - Medtronic MiniMed Paradigm Model MMT523 Insulin Pump - Class 2 Recall
Medtronic MiniMed Paradigm pump , model number MMT-523 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Medtronic Inc. - MiniMed Insulin Pump - Class 2 Recall
MiniMed Insulin Pump, model # MMT-508 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Abbott Gmbh & Co. KG - Alinity ciseries System Control Modul; LN 3R7001e e (SCM) - Class 2 Recall
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Impac Medical Systems, Inc. - MOSAIQ - Class 2 Recall
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - PowerPort M.R.I Implantable Port - Class 2 Recall
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, REF: 1809601, UDI: (01)00801741027147; 3. PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1859600, UDI: (01)00801741027208 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used fo...
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - Power Port Implantable Port - Class 2 Recall
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Without Suture Plugs, (01)00801741026737; 3. PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 1759600 Air Guard, With Suture Plugs, (01)00801741026850 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for in...
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - BardPort M.R.I. Hard Base Implantable Port - Class 2 Recall
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - BardPort M.R.I. Implantable Port - Class 2 Recall
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - BardPort Titanium Implantable Port - Class 2 Recall
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - Groshong CV Catheter - Class 2 Recall
1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - XPort isp M.R.I. Implantable Port - Class 2 Recall
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - PowerPort isp M.R.I. Implantable Port - Class 2 Recall
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, Ref: 1809661, UDI: (01)00801741027161 3. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1859660, UDI: (01)00801741027222 4. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter without Suture Plugs, Ref: 1859661, UDI:...
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - Vaccess CT PowerInjectable Implantable Port - Class 2 Recall
1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Bard Peripheral Vascular Inc - XPort isp M.R.I. Implantable Port - Class 2 Recall
PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

RAYSEARCH LABORATORIES AB - RayStation/RayPlan - Class 2 Recall
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts

Dexcom Inc - Dexcom G5 Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Dexcom Inc - Dexcom G6 Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Dexcom Inc - Dexcom G4 PLATINUM Continuous Glucose Monitoring System - Class 2 Recall
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Skytron, Div. The KMW Group, Inc - Skytron Ergon 3 Series Skyboom Monitor BracketFlatscreen Bracket - Class 2 Recall
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Signature Orthopaedics Europe Ltd - Encina HA Femoral Stem - Class 2 Recall
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Imager II 5F Angiographic Catheter - Class 1 Recall
Imager II 5F Angiographic Catheters, 5 units per package. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2020 Category: Medical Devices Source Type: alerts

Cook Inc. - Pericardiocentesis Set - Class 2 Recall
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts

Cook Inc. - Spectrum Central Venous Catheter Tray - Class 2 Recall
Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts

Capintec Inc - The Captus 4000e Thyroid Uptake system - Class 2 Recall
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy Programmer - Class 2 Recall
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2020 Category: Medical Devices Source Type: alerts

Intellijoint Surgical, Inc. - Intellijoint Navigation System - Class 2 Recall
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2020 Category: Medical Devices Source Type: alerts

Hill-Rom Inc. - NaviCare Patient Safety Software - Class 2 Recall
NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 23, 2020 Category: Medical Devices Source Type: alerts

Fresenius Medical Care Holdings, Inc. - Honeywell Pressure Transducer - Class 2 Recall
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens ADVIA Chemistry Direct Bilirubin_2 assay - Class 2 Recall
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts

MEDTRONIC ATS MEDICAL, INC. - Medtronic Open Pivot Aortic Valve Graft - Class 2 Recall
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Atellica CH Total Bilirubin_2 assay - Class 2 Recall
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measur...
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts

Randox Laboratories Ltd. - LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1, 2 AND 3 - Class 2 Recall
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Siemens Atellica CH Direct Bilirubin_2 assay - Class 2 Recall
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts