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.
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
FDA Device · Class II · 2022-01-26 · Covidien - Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blu…
FDA Device · Class II · 2022-01-26 · Compass Health Brands Corporate Office - Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (…
FDA Device · Class I · 2022-01-26 · Ev3 - KWIK-STIK 2 Pack, Catalog #0894P
FDA Device · Class II · 2022-01-26 · Microbiologics - Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014"…
FDA Device · Class I · 2022-01-26 · Ev3 - Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
FDA Device · Class II · 2022-01-26 · Philips North America - 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 tot…
FDA Device · Class II · 2022-01-26 · Greiner Bio One North America - Gentueri Viral Transport Medium (VTM), Sterile, IVD
FDA Device · Class II · 2022-01-26 · Gentueri - Infa-Therm Transport Mattress, Reference Number 989805616831 1015
FDA Device · Class II · 2022-01-26 · Philips North America - ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medi…
FDA Device · Class II · 2022-01-26 · Konica Minolta Healthcare Americas - Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
FDA Device · Class II · 2022-01-26 · Draeger Medical - Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
FDA Device · Class II · 2022-01-26 · Philips North America - VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
FDA Device · Class II · 2022-01-26 · Ortho Clinical Diagnostics - Heel Snuggler, Reference # 989805603411 99047
FDA Device · Class II · 2022-01-26 · Philips North America - 1. Sensis, material # 10764561
FDA Device · Class II · 2022-01-26 · Siemens Medical Solutions Usa - Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
FDA Device · Class II · 2022-01-26 · Straumann Usa - Infant Heel Warmers w/strap, Reference # 989805603201 1223
FDA Device · Class II · 2022-01-26 · Philips North America - Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
FDA Device · Class II · 2022-01-26 · Straumann Usa - OCT-Camera 211 01 A3
FDA Device · Class II · 2022-01-19 · Haag Streit Usa - SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Device · Class II · 2022-01-19 · Siemens Medical Solutions Usa - OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
FDA Device · Class II · 2022-01-19 · Haag Streit Usa - Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be u…
FDA Device · Class III · 2022-01-19 · Ki Mobility - GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile
FDA Device · Class II · 2022-01-19 · Technomed Europe - Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I)
FDA Device · Class II · 2022-01-19 · Ohio Medical - GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Regard, T AND A - Rogers, sterilized convenience kits
FDA Device · Class II · 2022-01-19 · Roi Cps - GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - SOMATOM Definition Edge -Computed tomography system Model 10590000
FDA Device · Class II · 2022-01-19 · Siemens Medical Solutions Usa - GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
FDA Device · Class II · 2022-01-19 · Covidien - SOMATOM Definition AS-Computed tomography system Model 8098027
FDA Device · Class II · 2022-01-19 · Siemens Medical Solutions Usa - GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia Syste…
FDA Device · Class I · 2022-01-19 · Getinge Usa Sales - GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (M…
FDA Device · Class II · 2022-01-19 · Medtronic Perfusion Systems - GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
FDA Device · Class II · 2022-01-19 · Ptw North America - SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Device · Class II · 2022-01-19 · Siemens Medical Solutions Usa - Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
FDA Device · Class II · 2022-01-19 · Gentherm Medical - Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue
FDA Device · Class II · 2022-01-19 · Philips North America - GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
FDA Device · Class II · 2022-01-19 · Depuy Orthopaedics - Proteus 235
FDA Device · Class II · 2022-01-19 · Ion Beam Applications - Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-800…
FDA Device · Class II · 2022-01-19 · Canon Medical System Usa - Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001…
FDA Device · Class II · 2022-01-19 · Philips North America - RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatmen…
FDA Device · Class II · 2022-01-19 · Reflexion Medical - Alinity m System, Part No. 08N53-002
FDA Device · Class II · 2022-01-12 · Abbott Molecular - Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro d…
FDA Device · Class II · 2022-01-12 · Siemens Healthcare Diagnostics - Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
FDA Device · Class II · 2022-01-12 · Diasorin Molecular - Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System
FDA Device · Class II · 2022-01-12 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Alinity m System, Part No. 08N53-002
FDA Device · Class II · 2022-01-12 · Abbott Molecular - DBB-06 Hemodialysis Delivery System
FDA Device · Class II · 2022-01-12 · Nikkiso Shizuoka Plant - DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
FDA Device · Class II · 2022-01-12 · Medshape - Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555
FDA Device · Class II · 2022-01-12 · Biomeme - Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R…
FDA Device · Class II · 2022-01-12 · Invacare - Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-…
FDA Device · Class II · 2022-01-12 · Invacare - Alinity m System, Part No. 08N53-002
FDA Device · Class II · 2022-01-12 · Abbott Molecular - Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in ord…
FDA Device · Class II · 2022-01-12 · Flower Orthopedics - QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075)
FDA Device · Class II · 2022-01-12 · Qiagen Sciences - iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pou…
FDA Device · Class III · 2022-01-12 · Tapemark - Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP…
FDA Device · Class II · 2022-01-12 · Invacare - UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile
FDA Device · Class II · 2022-01-12 · Uromedica - Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable…
FDA Device · Class II · 2022-01-12 · Howmedica Osteonics - Alinity m System, Part No. 08N53-002
FDA Device · Class II · 2022-01-12 · Abbott Molecular - Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China)
FDA Device · Class II · 2022-01-05 · Amo Manufacturing Usa - VIDAS Measles IgG (MSG), REF 30219
FDA Device · Class II · 2022-01-05 · Biomerieux - Model B35200 - Percept PC BrainSense Implantable Neurostimulator
FDA Device · Class II · 2022-01-05 · Medtronic Neuromodulation - VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Device · Class II · 2022-01-05 · Biomerieux - Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS)
FDA Device · Class II · 2022-01-05 · Karl Storz Endoscopy - VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS LH, REF 30406-01
FDA Device · Class II · 2022-01-05 · Biomerieux - RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Mumps IgG (MPG), REF 30218
FDA Device · Class II · 2022-01-05 · Biomerieux - ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of…
FDA Device · Class II · 2022-01-05 · Siemens Medical Solutions Usa - FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
FDA Device · Class II · 2022-01-05 · Migo Trading - iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States)
FDA Device · Class II · 2022-01-05 · Amo Manufacturing Usa - VIDAS Lyme IgM II (LYM), REF 416436
FDA Device · Class II · 2022-01-05 · Biomerieux - da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP10…
FDA Device · Class II · 2022-01-05 · Intuitive Surgical - VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS PRG Progesterone, REF 30409-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS RUB IgG (RBG), REF 30226
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Lyme IgG II (LYM), REF 417401
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Clostridium Difficile GDH, REF 30125-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS SARS-COV-2 IgG, Ref 423834-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS Estradiol II, REF 30431-01
FDA Device · Class II · 2022-01-05 · Biomerieux - Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for t…
FDA Device · Class II · 2022-01-05 · Forbes Rehab Services - VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Device · Class II · 2022-01-05 · Biomerieux - VIDAS FSH, REF 30407-01
FDA Device · Class II · 2022-01-05 · Biomerieux - Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
FDA Device · Class II · 2022-01-05 · Abbott - Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human ser…
FDA Device · Class II · 2022-01-05 · Siemens Healthcare Diagnostics
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)