Siemens Medical Solutions USA, Inc - Siemens Artis Icono Biplane - Class 2 Recall
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens ARTIS Icono Floor - Class 2 Recall
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Artis Pheno - Class 2 Recall
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2022 Category: Medical Devices Source Type: alerts

Microbiologics Inc - KWIKSTIK and LYFO DISK - Class 2 Recall
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Compass Health Brands (Corporate Office) - Compass Health Rollator Mechanical Walker - Class 2 Recall
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Covidien, LP - SonarMed AirWave - Class 2 Recall
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT) (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Infant Heel Warmers w/strap - Class 2 Recall
Infant Heel Warmers w/strap, Reference # 989805603201 1223 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Cardinal Infant Heel Warmer - Class 2 Recall
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Medichoice Infant Heel Warmer - Class 2 Recall
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Heel Snuggler - Class 2 Recall
Heel Snuggler, Reference # 989805603411 99047 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Straumann USA LLC - Neodent - Class 2 Recall
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Straumann USA LLC - Neodent - Class 2 Recall
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

ev3 Inc. - HawkOne - Class 1 Recall
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

ev3 Inc. - HawkOne - Class 1 Recall
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 20, 2022 Category: Medical Devices Source Type: alerts

Ortho-Clinical Diagnostics, Inc. - VITROS High Sample Diluent A (HSDA) - Class 2 Recall
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Infatherm Infant Transport Mattress; Model Number 989805616831 - Class 2 Recall
Infa-Therm Transport Mattress, Reference Number 989805616831 1015 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2022 Category: Medical Devices Source Type: alerts

Gentueri Inc - Transport Culture Medium - Class 2 Recall
Gentueri Viral Transport Medium (VTM), Sterile, IVD (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2022 Category: Medical Devices Source Type: alerts

Greiner Bio-One North America, Inc. - Class 2 Recall
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 19, 2022 Category: Medical Devices Source Type: alerts

Konica Minolta Healthcare Americas, Inc. - Class 2 Recall
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Luminex Corporation - ARIES HSV 1&2 Assay - Class 2 Recall
ARIES HSV 1&2 Assay, Part Number/REF 50-10017 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Programmable Diagnostic Computer - Class 2 Recall
1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - Fabius MRI - Class 2 Recall
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Stanley Security Solutions Inc - Powered Environmental Control System - Class 2 Recall
Senior Living Arial Emergency and Nurse Call Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Covidien Llc - LigaSure Blunt Tip Laparoscopic Sealer/Divider, NanoCoated - Class 2 Recall
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2022 Category: Medical Devices Source Type: alerts

Gentherm Medical, LLC - ElectriCool II Portable Cold Therapy Unit - Class 2 Recall
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2022 Category: Medical Devices Source Type: alerts

Medtronic Perfusion Systems - Medtronic Perfusion Tubing Packs - Class 2 Recall
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. C...
Source: Medical Device Recalls - January 13, 2022 Category: Medical Devices Source Type: alerts

Canon Medical System, USA, INC. - Flat Panel Detector - Class 2 Recall
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2022 Category: Medical Devices Source Type: alerts

PTW NORTH AMERICA CORPORATION - Class 2 Recall
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE REV STEM - Class 2 Recall
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE REV STEM - Class 2 Recall
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

DePuy Orthopaedics, Inc. - GLOBAL UNITE STD STEM - Class 2 Recall
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

Ohio Medical Corporation - Instavac - Class 2 Recall
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2022 Category: Medical Devices Source Type: alerts

Haag-Streit USA Inc - Haag Streit Surgical - Class 2 Recall
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Haag-Streit USA Inc - Haag Streit Surgical - Class 2 Recall
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

ROi CPS LLC - Regard - Class 2 Recall
Regard, T AND A - Rogers, sterilized convenience kits (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition AS - Class 2 Recall
SOMATOM Definition AS-Computed tomography system Model 8098027 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition Edge - Class 2 Recall
SOMATOM Definition Edge -Computed tomography system Model 10590000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Confidence - Class 2 Recall
SOMATOM Confidence -Computed tomography systems Model 10590100 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Edge Plus - Class 2 Recall
SOMATOM Edge Plus-Computed tomography system Model 1026700 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Azurion R2.0 - Class 2 Recall
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Getinge Usa Sales Inc - Vaporizer Sevoflurane, Maquet Filling - Class 1 Recall
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Reflexion Medical, Inc. - RefleXion X1 System - Class 2 Recall
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Philips North America Llc - Allura Xper; Azurion - Class 2 Recall
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459...
Source: Medical Device Recalls - January 11, 2022 Category: Medical Devices Source Type: alerts

Technomed Europe - Disposable Subdermal Needle Electrode - Class 2 Recall
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2022 Category: Medical Devices Source Type: alerts

Ki Mobility Llc - Mechanical Chair With Casters - Class 3 Recall
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2022 Category: Medical Devices Source Type: alerts