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.
- ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Num…
FDA Device · Class II · 2022-02-16 · Depuy Orthopaedics - Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmona…
FDA Device · Class II · 2022-02-16 · Fresenius Medical Care Holdings - ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number…
FDA Device · Class II · 2022-02-16 · Depuy Orthopaedics - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR 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 Discovery MR450 1.5T system, nuclear magnetic resonance imaging syst…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
FDA Device · Class II · 2022-02-16 · Gentueri - Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tib…
FDA Device · Class II · 2022-02-16 · Synthes Usa Products - GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
FDA Device · Class II · 2022-02-16 · Avanos Medical - KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack
FDA Device · Class II · 2022-02-16 · Microbiologics - QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set
FDA Device · Class II · 2022-02-16 · Microbiologics - Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - E25Bio COVID-19 Direct Antigen Rapid Test
FDA Device · Class I · 2022-02-16 · E25bio - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR Sy…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture)
FDA Device · Class II · 2022-02-16 · Microbiologics - KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
FDA Device · Class III · 2022-02-16 · Microbiologics - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus
FDA Device · Class III · 2022-02-16 · Microbiologics - GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging sys…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic reson…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
FDA Device · Class II · 2022-02-16 · Mallinckrodt Pharmaceuticals Ireland - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR 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 Brivo MR355 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 SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magn…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra 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 SIGNA MR380 System, nuclear magnetic resonance system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - QC Sets and Panels: KWIK-STIK" 2 Pack
FDA Device · Class II · 2022-02-16 · Microbiologics - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
FDA Device · Class II · 2022-02-16 · Baxter Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable…
FDA Device · Class II · 2022-02-16 · Microbiologics - GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging syst…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - CURAD REUSABLE GEL HOT/COLD PACK
FDA Device · Class II · 2022-02-16 · Medline Industries Northfield - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon…
FDA Device · Class II · 2022-02-16 · Ge Healthcare - GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system
FDA Device · Class II · 2022-02-16 · Ge Healthcare - ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Device · Class II · 2022-02-09 · Luminex - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from…
FDA Device · Class III · 2022-02-09 · Microbiologics - HARDY DIAGNOSTICS CatScreen, 25dsk/vial
FDA Device · Class II · 2022-02-09 · Medline Industries Northfield - The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vagi…
FDA Device · Class II · 2022-02-09 · Femselect - OXY-1 System, Model Number 001-0500-001
FDA Device · Class I · 2022-02-09 · Abiomed - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2
FDA Device · Class I · 2022-02-09 · Baxter Healthcare - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2,…
FDA Device · Class II · 2022-02-09 · Philips North America - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - Premier Rotaclone, Rx only
FDA Device · Class II · 2022-02-09 · Medline Industries Northfield - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm
FDA Device · Class II · 2022-02-09 · Covidien - KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack
FDA Device · Class III · 2022-02-09 · Microbiologics - KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack
FDA Device · Class III · 2022-02-09 · Microbiologics - ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Device · Class II · 2022-02-09 · Siemens Medical Solutions Usa - CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, I…
FDA Device · Class II · 2022-02-09 · Immuno Mycologics - CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Device · Class I · 2022-02-09 · Empowered Diagnostics - X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System
FDA Device · Class II · 2022-02-09 · Xtant Medical - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa - INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
FDA Device · Class II · 2022-02-09 · Smith And Nephew - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and h…
FDA Device · Class II · 2022-02-09 · Olympus - YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider t…
FDA Device · Class II · 2022-02-09 · Young Dental Mfg I - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
FDA Device · Class II · 2022-02-09 · Dixi Medical Usa - ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Device · Class I · 2022-02-09 · Empowered Diagnostics - Baxter Spectrum IQ Infusion Pumps, Product code 3570009
FDA Device · Class I · 2022-02-09 · Baxter Healthcare - Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01
FDA Device · Class II · 2022-02-09 · Celltrion Usa - Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Device · Class II · 2022-02-02 · Siemens Medical Solutions Usa - GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - GE Vscan Extend, being sold as "Vscan Extend Sector USB"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermit…
FDA Device · Class I · 2022-02-02 · Philips Respironics - Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
FDA Device · Class II · 2022-02-02 · Siemens Medical Solutions Usa - MAGEC 1 System
FDA Device · Class II · 2022-02-02 · Nuvasive Specialized Orthopedics - PIVO Blood Collection Device 20G, REF: 202-0005
FDA Device · Class II · 2022-02-02 · Velano Vascular - Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positi…
FDA Device · Class I · 2022-02-02 · Philips Respironics - GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
FDA Device · Class II · 2022-02-02 · Siemens Medical Solutions Usa - GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - GE Vscan Extend, being sold as "Vscan Extend Dual USB"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - 8mm FlexDex Needle Driver, Product Code FD-335 ND
FDA Device · Class II · 2022-02-02 · Flexdex - API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts
FDA Device · Class II · 2022-02-02 · Biomerieux - 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C de…
FDA Device · Class II · 2022-02-02 · Nrt X Ray A S - GE Vscan Extend, being sold as "Vscan Extend Console"
FDA Device · Class II · 2022-02-02 · Ge Healthcare - Senior Living Arial Emergency and Nurse Call Systems
FDA Device · Class II · 2022-01-26 · Stanley Security Solutions - ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Device · Class II · 2022-01-26 · Luminex
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)