FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- Microbiologics QC Sets and Panels
FDA Device · Class II · 2022-03-09 · Microbiologics - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics - Bronchial Microbiology Brush, Catalog Number 4310 and 4320
FDA Device · Class II · 2022-03-09 · Hobbs Medical - BUTLER Clear Dip, 12 bottles/case
FDA Device · Class II · 2022-03-09 · Sunstar Americas - Everest MI XT Outer Dilator, Catalog Number 5101-90168
FDA Device · Class II · 2022-03-09 · K2m - LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
FDA Device · Class II · 2022-03-09 · Microbiologics - Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Device · Class II · 2022-03-09 · Lacrimedics - KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6…
FDA Device · Class II · 2022-03-09 · Microbiologics - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
FDA Device · Class II · 2022-03-09 · Biopro - da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
FDA Device · Class II · 2022-03-09 · Intuitive Surgical - Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
FDA Device · Class II · 2022-03-09 · Biopro - Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Device · Class I · 2022-03-09 · Celltrion Usa - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
FDA Device · Class II · 2022-03-09 · Biopro - The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium
FDA Device · Class II · 2022-03-09 · Wright Medical Technology - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics - Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
FDA Device · Class II · 2022-03-09 · Biopro - Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
FDA Device · Class II · 2022-03-09 · Brasseler Usa Medical - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
FDA Device · Class II · 2022-03-09 · Biopro - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
FDA Device · Class II · 2022-03-09 · Biopro - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
FDA Device · Class II · 2022-03-09 · Biopro - Everest MI XT Inner Dilator, Catalog Number 5101-90167
FDA Device · Class II · 2022-03-09 · K2m - MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Device · Class II · 2022-03-09 · Stryker Leibinger And Kg - Digital Angiography System Bransist safire Generator Model D150GC-40
FDA Device · Class II · 2022-03-09 · Shimadzu Medical Systems - OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Device · Class II · 2022-03-09 · Lacrimedics - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
FDA Device · Class II · 2022-03-09 · Biopro - MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
FDA Device · Class II · 2022-03-09 · Medline Industries Northfield - KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
FDA Device · Class II · 2022-03-09 · Microbiologics - Microbiologics QC Sets and Panels: Helix Elite
FDA Device · Class II · 2022-03-09 · Microbiologics - AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Device · Class II · 2022-03-09 · Beckman Coulter - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
FDA Device · Class II · 2022-03-09 · Biopro - Helix Elite" Molecular Standards: Inactivated Standard
FDA Device · Class II · 2022-03-09 · Microbiologics - Philips Respironics V60 Ventilator Part Number 1053617
FDA Device · Class I · 2022-03-09 · Respironics California - Alinity m Integrated Reaction Units (IRU)
FDA Device · Class II · 2022-03-09 · Abbott Molecular - Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
FDA Device · Class II · 2022-03-09 · Acorn Stairlifts - Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Device · Class I · 2022-03-09 · Celltrion Usa - QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture)
FDA Device · Class II · 2022-03-09 · Microbiologics - Philips Respironics V60 Plus Ventilator Part Number 1138747
FDA Device · Class I · 2022-03-09 · Respironics California - Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
FDA Device · Class II · 2022-03-02 · Biomet - BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
FDA Device · Class II · 2022-03-02 · C R Bard - Michels Transport Medium, 20ML Prefilled Cont
FDA Device · Class II · 2022-03-02 · Medline Industries Northfield - IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
FDA Device · Class II · 2022-03-02 · Natus Neurology - DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
FDA Device · Class II · 2022-03-02 · Collagen Matrix - RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter
FDA Device · Class II · 2022-03-02 · Collagen Matrix - BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
FDA Device · Class II · 2022-03-02 · C R Bard - Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
FDA Device · Class II · 2022-03-02 · Biomet - Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE
FDA Device · Class II · 2022-03-02 · Medtronic Vascular - NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
FDA Device · Class II · 2022-03-02 · Nobel Biocare Usa - Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
FDA Device · Class II · 2022-03-02 · Biomet - meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box
FDA Device · Class II · 2022-03-02 · Medline Industries Northfield - BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equippe…
FDA Device · Class III · 2022-03-02 · Becton Dickinson And - Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
FDA Device · Class II · 2022-03-02 · Biomet - Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
FDA Device · Class II · 2022-03-02 · Biomet - REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
FDA Device · Class II · 2022-03-02 · Stryker Sustainability Solutions - Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
FDA Device · Class II · 2022-03-02 · Biomet - Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
FDA Device · Class II · 2022-03-02 · Biomet - Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
FDA Device · Class II · 2022-03-02 · Biomet - The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless…
FDA Device · Class II · 2022-03-02 · Balt Usa - Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
FDA Device · Class II · 2022-02-23 · Hill Rom - 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
FDA Device · Class II · 2022-02-23 · Howmedica Osteonics - FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Device · Class II · 2022-02-23 · Envisiontec Us - Destino Twist 14F (also branded as Guidestar 14F)
FDA Device · Class II · 2022-02-23 · Oscor - Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Per…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130
FDA Device · Class I · 2022-02-23 · Vyaire Medical - Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
FDA Device · Class II · 2022-02-23 · Howmedica Osteonics - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Veradius Unity, Model #718132
FDA Device · Class II · 2022-02-23 · Philips Medical Systems Nederland B V - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time peri…
FDA Device · Class II · 2022-02-23 · Smiths Medical Asd - KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
FDA Device · Class III · 2022-02-23 · Microbiologics - RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen col…
FDA Device · Class I · 2022-02-23 · Base 10 Genetics - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, T…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
FDA Device · Class II · 2022-02-23 · Howmedica Osteonics - Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotol…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - Zenition 50, Model #718096
FDA Device · Class II · 2022-02-23 · Philips Medical Systems Nederland B V - FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Device · Class II · 2022-02-23 · Envisiontec Us - Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
FDA Device · Class II · 2022-02-23 · Howmedica Osteonics - Zenition 70, Model #718133
FDA Device · Class II · 2022-02-23 · Philips Medical Systems Nederland B V - Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
FDA Device · Class II · 2022-02-23 · Hill Rom - 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-6…
FDA Device · Class I · 2022-02-23 · Teleflex Medical - OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their access…
FDA Device · Class II · 2022-02-23 · Olympus - Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Device · Class II · 2022-02-23 · Merete Medical - LYSO Disk(TM) labeled as containing Actinomyces odontolyticus
FDA Device · Class III · 2022-02-16 · Microbiologics - LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
FDA Device · Class II · 2022-02-16 · Microbiologics - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Techn…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
FDA Device · Class II · 2022-02-16 · Avanos Medical - Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic s…
FDA Device · Class II · 2022-02-16 · Smith And Nephew - BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings
FDA Device · Class II · 2022-02-16 · Becton Dickinson And - KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6…
FDA Device · Class II · 2022-02-16 · Microbiologics - QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set
FDA Device · Class II · 2022-02-16 · Microbiologics - GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic r…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
FDA Device · Class II · 2022-02-16 · Argon Medical Devices - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imagin…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imagi…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - R82 by ETAC Push Brace for High-Low
FDA Device · Class II · 2022-02-16 · R82 A S
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