Siemens Medical Solutions USA, Inc - Siemens SOMATOM Go.Now - Class 2 Recall
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens SOMATOM Go.Up - Class 2 Recall
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Olsen Medical - Monopolar Cord - Class 2 Recall
Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Olsen Medical - bipolar cord - Class 2 Recall
Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 (h) Bipolar Cord, 28 mm ...
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Olsen Medical - monopolar forceps - Class 2 Recall
Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Olsen Medical - bipolar forceps - Class 2 Recall
Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, ...
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Ad-Tech Medical Instrument Corporation - Disposable Drill Kit - Class 2 Recall
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Olsen Medical - monopolar pencil - Class 2 Recall
Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Maquet SAS - VOLISTA - Class 2 Recall
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - Syva Emit 2000 Theophylline Assay - Class 2 Recall
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Medline Industries Inc - MEDLINE Sterile Needle Counter - Class 2 Recall
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - Edwards Lifesciences IntraClude IntraAortic Occlusion Device - Class 2 Recall
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Siemens Biograph Horizon - Class 2 Recall
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 25, 2018 Category: Medical Devices Source Type: alerts

Philips Electronics North America Corp. - Philips HeartStart FRx AED - Class 2 Recall
Philips HeartStart FRx AED. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - Ziptight Ankle Syndesmosis Fixation - Class 2 Recall
Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Philips Electronics North America Corp. - Philips HeartStart (HS1) (Onsite/Home) AED - Class 2 Recall
Philips HeartStart (HS1) Onsite/Home AED (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

LivaNova USA - INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir - Class 2 Recall
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It col...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Implant Direct Sybron Manufacturing, LLC - Legacy 4 Implant - Class 2 Recall
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

LivaNova USA - INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir - Class 2 Recall
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It co...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Prismaflex System - Class 2 Recall
Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescrib...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Prismaflex 7.XX - Class 2 Recall
Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescr...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Teleflex Medical Europe Ltd - Teleflex MEDICAL LMA(TM) MADgic(TM) - Class 2 Recall
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Prismaflex 7.20 - Class 2 Recall
Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescri...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Prismaflex 7.XX - Class 2 Recall
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescri...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Prismaflex 5.10 US - Class 2 Recall
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescri...
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Synthes (USA) Products LLC - Synthes Torque Limiting Handle - Class 2 Recall
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Implant Direct Sybron Manufacturing, LLC - ImplantDirect simply InterActive Implant, Part 655010U - Class 2 Recall
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Spinal Elements - AMENDIA Omega Lumbar Interbody Fusion Device - Class 2 Recall
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The ¿LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION(R) CR XLPE HIGH LEXION Articular Insert - Class 2 Recall
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION(R) CR XLPE HIGH LEXION Articular Insert - Class 2 Recall
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION(R) CR XLPE HIGH LEXION Articular Insert - Class 2 Recall
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION(R) CR XLPE HIGH LEXION Articular Insert - Class 2 Recall
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Baxter EXACTAMIX Inlet, Vented, MicroVolume Inlet - Class 2 Recall
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Baxter EXACTAMIX Inlet, Syringe Inlet - Class 2 Recall
Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Baxter EXACTAMIX Inlet, Vented, HighVolume Inlet - Class 2 Recall
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Baxter EXACTAMIX Inlet, NonVented, HighVolume Inlet - Class 2 Recall
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - 5o (degree) GENESIS(R) II VALGUS BUSHING - Class 2 Recall
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are 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 la...
Source: Medical Device Recalls - May 22, 2018 Category: Medical Devices Source Type: alerts

LivaNova USA - Stockert HeaterCooler System 3T - Class 2 Recall
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Beckman Coulter Inc. - iChem(R) VELOCITY Urine Chemistry Strips - Class 2 Recall
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, ...
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

LivaNova USA - Stckert HeaterCooler System 3T - Class 2 Recall
Sorin St¿ckert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Madison Polymeric Engineering - First Step Endoscopic Cleaning Pad with 4 Button Brush - Class 2 Recall
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Madison Polymeric Engineering - First Step Endoscopic Cleaning Pad - Class 2 Recall
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Madison Polymeric Engineering - First Step Endoscopic Cleaning Pad - Class 2 Recall
First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Madison Polymeric Engineering - Travel Kit - Class 2 Recall
Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts

Madison Polymeric Engineering - Draco Enzymatic DeepCleaning Pad - Class 2 Recall
Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts