Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Maquet Cardiovascular Us Sales, Llc - Class 2 Recall
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Tecan US, Inc. - Freedom EVO2 - Class 2 Recall
Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Arkray Factory USA, Inc. - AUTION HYBRID AU4050 - Class 2 Recall
AUTION HYBRID AU-4050 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Stryker GmbH - Endotrac EPF/EGR Hook/Triangle Blade Kit - Class 2 Recall
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Stryker GmbH - Endotrac ECTR Hook/Triangle Blade Kit - Class 2 Recall
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 2019 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screw - Class 2 Recall
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the...
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - ETHIBOND EXCEL ETHIBOND Polvester Suture - Class 2 Recall
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - ETHIBOND EXCEL Polyester Suture - Class 2 Recall
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan HVT - Class 1 Recall
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Sheridan/HVT Novaplus - Class 1 Recall
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Sheridan/CF Novaplus - Class 1 Recall
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan Preformed - Class 1 Recall
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan LTS - Class 1 Recall
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan CF - Class 1 Recall
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan Uncuffed - Class 1 Recall
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Teleflex Medical - Hudson RCI Sheridan EZENDO - Class 1 Recall
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery Ml DR - Class 2 Recall
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery PET/CT 610 - Class 2 Recall
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery Ml - Class 2 Recall
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Optima PET/CT 560, 560FX - Class 2 Recall
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery IQ - Class 2 Recall
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Discovery PET/CT 710 - Class 2 Recall
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Cytocell Ltd. - Aquarius D13S319 Plus Deletion Probe - Class 3 Recall
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

CooperSurgical, Inc. - LEEP Precision Integrated System - Class 2 Recall
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clini...
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Cook Inc. - Zenith Alpha Abdominal Endovascular Graft - Class 2 Recall
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 20, 2019 Category: Medical Devices Source Type: alerts

Microbiologics Inc - Cepheid Xpert C. difficile/Epi Control Panel - Class 3 Recall
Cepheid Xpert C. difficile/Epi Control Panel (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 19, 2019 Category: Medical Devices Source Type: alerts

Med Tec Inc - CIVCO Solstice(TM) SRS Immobilization System - Class 2 Recall
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient po...
Source: Medical Device Recalls - June 19, 2019 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - Vscan Extend - Class 2 Recall
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It s...
Source: Medical Device Recalls - June 19, 2019 Category: Medical Devices Source Type: alerts

Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts

Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts

Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
EGIA45 CT AR MD THK REL, EGIA45CTAMT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts

Covidien LLC - Endo GIA Articulating Reloads with TriStaple Technology - Class 2 Recall
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2019 Category: Medical Devices Source Type: alerts