FDA (Device enforcement)

11,102 recalls · page 69 of 112

• CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators2023-05-10
• CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators2023-05-10
• ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators2023-05-10
• CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators2023-05-10
• CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators2023-05-10
• CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators2023-05-10
• CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators2023-05-10
• ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators2023-05-10
• ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators2023-05-10
• QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influ2023-05-09
• Philips Tempus LS-Manual Defibrillator, Part Number: 00-30202023-05-08
• Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-162023-05-08
• Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)2023-05-08
• VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. 2023-05-08
• BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only2023-05-08
• Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy2023-05-05
• bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator2023-05-05
• bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator2023-05-05
• Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A2023-05-04
• Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B2023-05-04
• Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A2023-05-04
• Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B2023-05-04
• Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA26402023-05-04
• Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA26332023-05-04
• BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:1100451542023-05-04
• BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1100451602023-05-04
• BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1100451502023-05-04
• BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1100451512023-05-04
• Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1100451562023-05-04
• Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1100451572023-05-04
• NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device2023-05-03
• The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advance2023-05-03
• MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel2023-05-03
• Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medial)2023-05-02
• Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis2023-05-02
• Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-1002023-05-02
• Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM2023-05-02
• V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).2023-05-02
• LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;2023-05-02
• Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT22023-05-01
• Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B2023-05-01
• Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B2023-05-01
• Trilogy Evo Universal Ventilator, Model Number DS2000X11B2023-05-01
• Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation2023-04-28
• QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 6912232023-04-28
• Intelli-C, Right side suspended Tabletop, REF: 034000002023-04-27
• Intelli-C, Left side suspended Tabletop, REF: 034000102023-04-27
• HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P2023-04-26
• SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB2023-04-25
• Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 59554602023-04-25