FDA (Device enforcement)

11,102 recalls · page 82 of 112

• Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 110660012022-04-13
• Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 110660002022-04-13
• Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt 2022-04-12
• Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q12022-04-12
• (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile2022-04-11
• (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.2022-04-11
• AC-powered adjustable medical beds with built-in electric DC actuators and controls.2022-04-11
• AC-powered adjustable medical beds with built-in electric DC actuators and controls.2022-04-11
• Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 113276002022-04-11
• Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 113277002022-04-11
• HemosIL ReadiPlasTin, Part No. 00203014002022-04-08
• TMJ Arthroscopy Drape, 85''x 96''2022-04-08
• Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE2022-04-08
• XVIVO Organ Chamber REF 190202022-04-08
• Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.2022-04-07
• Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-30002022-04-07
• TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,2022-04-06
• 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)2022-04-01
• 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)2022-04-01
• CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK12022-04-01
• 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US2022-04-01
• 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)2022-04-01
• 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)2022-04-01
• 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)2022-04-01
• 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)2022-04-01
• 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-B2022-04-01
• 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA2022-04-01
• 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-R2022-04-01
• 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-R2022-04-01
• Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.2022-04-01
• Turbett Surgical Container, TS15002022-04-01
• Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO2022-03-30
• HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number11042022-03-30
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit2022-03-30
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14202022-03-30
• HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.02022-03-30
• Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Cat2022-03-30
• Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.2022-03-30
• Percept BrainSense Implantable Neurostimulator (INS), Model B352002022-03-30
• Percept PC BrainSense Implantable Neurostimulator (INS) Model B352002022-03-30
• Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V2022-03-30
• Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-5002022-03-30
• The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and 2022-03-29
• Smart Toe II Intramedullary Arthrodesis Implant2022-03-28
• Puritan Bennett 980 Series Ventilator2022-03-25
• K-Wire, 1.35 mm x 170 mm2022-03-25
• CK MB Calibrator, Catalogue Number CK23932022-03-25
• VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 19319222022-03-25
• VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 13501982022-03-25
• VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 18497932022-03-25
• BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.2022-03-25
• BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.2022-03-25
• Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.2022-03-24
• Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.2022-03-24
• TearCare version 1.0 SmartHubs2022-03-23
• Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM05008013P2022-03-23
• Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only2022-03-23
• 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack2022-03-22
• ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.12022-03-21
• Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 0073842022-03-21
• WAVES WCM Kidney Cassette Module2022-03-21
• Avanos Cortrak 2 Enteral Access System (EAS)2022-03-21
• da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 4804602022-03-17
• MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-0082022-03-16
• ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.2022-03-16
• LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.2022-03-16
• Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves2022-03-15
• CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US2022-03-15
• CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US2022-03-15
• CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US2022-03-15
• CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US2022-03-15
• CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US2022-03-15
• CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US2022-03-15
• PrisMax System, Product Code 9556262022-03-15
• PrisMax System, Product Code 9557242022-03-15
• PrisMax System, Product Codes: a) 955558, b) 955627, c) 9557012022-03-15
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.2022-03-14
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.2022-03-14
• Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.2022-03-14
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.2022-03-14
• Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.2022-03-14
• 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)2022-03-11
• 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)2022-03-11
• 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)2022-03-11
• INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)2022-03-11
• Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)2022-03-11
• VELYS Robotic-Assisted Solution Base Product No.: 4515701002022-03-11
• Merlin PCS 3650 programmer Model 3330 software2022-03-10
• Merlin 2 PCS MER3700 programmer Model MER3400 software2022-03-10
• Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q2022-03-10
• Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q2022-03-10
• Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q2022-03-10
• Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box2022-03-09
• 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-400102022-03-09
• 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-400122022-03-09
• BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.102022-03-09
• ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.2022-03-08
• ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy2022-03-08
• ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support2022-03-08
• OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG4121432022-03-08