Getinge Group Logistics America, LLC - Flowi Anesthesia System, Flowc Anesthesia System, Flowe Anesthesia System - Class 2 Recall
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

OraSure Technologies, Inc. - OraSure Methamphetamine Intercept Microplate EIA - Class 3 Recall
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - VentStar - Class 2 Recall
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - ID Basic - Class 2 Recall
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - VentStar - Class 2 Recall
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - VentStar - Class 2 Recall
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Sunstar Americas, Inc. - G.U.M. HYDRAL DRY MOUTH RELIEF - Class 2 Recall
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2021 Category: Medical Devices Source Type: alerts

Barco N.V. - Barco MDNC3421 DISPLAY, DIAGNOSTIC RADIOLOGY - Class 2 Recall
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Class 2 Recall
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

Acist Medical Systems - ACIST Kodama Intravascular Ultrasound Catheter - Class 1 Recall
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Captivator II SingleUse Polypectomy Snares - Class 2 Recall
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Captivator SingleUse Polypectomy Snares, Captiflex SingleUse Polypectomy Snares - Class 2 Recall
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - Captivator/Captiflex/Sensation Short Throw SingleUse Polypectomy Snares - Class 2 Recall
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2021 Category: Medical Devices Source Type: alerts

G & H Wire Company - FlexMedics Patient Packs - Class 2 Recall
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2021 Category: Medical Devices Source Type: alerts

Johnson & Johnson Surgical Vision Inc - TECNIS Toric 1Piece - Class 2 Recall
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2021 Category: Medical Devices Source Type: alerts

Nihon Kohden America Inc - WMTS Telemetry Receiver, Multiple Patient Receiver - Class 2 Recall
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2021 Category: Medical Devices Source Type: alerts

ReNovo, Inc. - Arthroscopes and accessories - Class 2 Recall
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2021 Category: Medical Devices Source Type: alerts

Shanghai United Imaging Healthcare Co., Ltd. - Stationary xray system - Class 2 Recall
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2021 Category: Medical Devices Source Type: alerts

BioFire Diagnostics, LLC - FilmArray Blood Culture Identification (BCID) Panel/ Blood Culture Identification 2 (BCID2) Panel - Class 2 Recall
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2021 Category: Medical Devices Source Type: alerts

BioFire Diagnostics, LLC - FilmArray Blood Culture Identification (BCID) Panel/ Blood Culture Identification 2 (BCID2) Panel - Class 2 Recall
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 2, 2021 Category: Medical Devices Source Type: alerts

Hamilton Co - STATION, PIPETTING AND DILUTING, FOR CLINICAL USE - Class 2 Recall
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2021 Category: Medical Devices Source Type: alerts

Bovie Medical Corporation - HNM Disposable Bipolar Ablators - Class 2 Recall
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2021 Category: Medical Devices Source Type: alerts

Bovie Medical Corporation - ConMed Disposable Bipolar Ablators - Class 2 Recall
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2021 Category: Medical Devices Source Type: alerts

Bovie Medical Corporation - Velocity Disposable Bipolar Ablators - Class 2 Recall
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2021 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - PrisMax System - Class 2 Recall
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2021 Category: Medical Devices Source Type: alerts

CooperSurgical, Inc. - Milex Gellhorn/Flexible ShortStem Pessary 2 with & without kit - Class 2 Recall
The Milex¿ GELLHORN Pessary - Product Usage: is a medical device made from silicone that is inserted into the vagina to function as a supportive structure of the uterus, bladder, and/or rectum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2021 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with Master Drug Library V6, V8, Spectrum IQ with Dose IQ Safety Softwa - Class 2 Recall
Infusion Pump (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2021 Category: Medical Devices Source Type: alerts

Northgate Technologies, Inc. - Steris CO2MPACT Endoscopic Insufflator - Class 2 Recall
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2021 Category: Medical Devices Source Type: alerts

Northgate Technologies, Inc. - ConMed 50L abdominal insufflator - Class 2 Recall
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2021 Category: Medical Devices Source Type: alerts

Steris Corporation - OT Surgical Table - Class 2 Recall
OT1000 Series Orthopedic Surgical Tables (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2021 Category: Medical Devices Source Type: alerts

Smiths Medical ASD Inc. - Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube - Class 2 Recall
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2021 Category: Medical Devices Source Type: alerts

Silk Road Medical Inc - ENROUTE Transcarotid Stent System - Class 2 Recall
ENROUTE Transcarotid Stent System REF SR-XXYY-CS (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2021 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTIS Icono - Class 2 Recall
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2021 Category: Medical Devices Source Type: alerts

Natus Manufacturing Limited - Natus EDS3 CSF External Drainage System - Class 2 Recall
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2021 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2021 Category: Medical Devices Source Type: alerts

Ecolab Inc - Slush Warmer Disc Drape - Class 2 Recall
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2021 Category: Medical Devices Source Type: alerts

Ortho-Clinical Diagnostics, Inc. - VITROS Chemistry Products VersaTips - Class 2 Recall
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

DeRoyal Industries Inc - CV Basin Procedure Pack - Class 2 Recall
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

DeRoyal Industries Inc - CV Basin Procedure Pack - Class 2 Recall
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

DeRoyal Industries Inc - Heart Pack - Class 2 Recall
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Respironics California, LLC - Philips V60 Ventilator - Class 2 Recall
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Combat Medical Systems, LLC - Fresh Whole Blood Donor Set - Class 1 Recall
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Combat Medical Systems, LLC - Low Titer Type O FWB Transfusion Set - Class 1 Recall
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Combat Medical Systems, LLC - Fresh Whole Blood Transfusion Set - Class 1 Recall
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Combat Medical Systems, LLC - Valkyrie LTOWB Administration - Class 1 Recall
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Combat Medical Systems, LLC - Valkyrie LTOWB Collection - Class 1 Recall
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Medline Industries Inc - Stanbio - Class 3 Recall
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 20, 2021 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - EMBLEM - Class 2 Recall
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2021 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - EMBLEM - Class 2 Recall
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2021 Category: Medical Devices Source Type: alerts

Carl Zeiss Meditec AG - IOLMaster 700 - Class 2 Recall
IOLMaster 700 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2021 Category: Medical Devices Source Type: alerts