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.
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
FDA Device · Class II · 2022-05-25 · Heartware - DxM 1040 MicroScan WalkAway Instrument REF B1018-440
FDA Device · Class II · 2022-05-25 · Beckman Coulter - NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emerge…
FDA Device · Class II · 2022-05-25 · Baxter Healthcare - Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW
FDA Device · Class II · 2022-05-25 · Getinge Usa Sales - EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
FDA Device · Class II · 2022-05-25 · Boston Scientific - Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electroly…
FDA Device · Class II · 2022-05-25 · Total Resources Intl - Atrium Advanta V12 Covered Stent System (OUS only)
FDA Device · Class I · 2022-05-25 · Atrium Medical - VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
FDA Device · Class II · 2022-05-25 · Luminex - Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086…
FDA Device · Class II · 2022-05-25 · Total Resources Intl - MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
FDA Device · Class II · 2022-05-25 · Beckman Coulter - Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Device · Class I · 2022-05-25 · Abbott Vascular - Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergenc…
FDA Device · Class II · 2022-05-25 · Baxter Healthcare - EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
FDA Device · Class II · 2022-05-25 · Boston Scientific - Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System
FDA Device · Class II · 2022-05-25 · Medtronic - BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Device · Class II · 2022-05-25 · Bio Rad Laboratories - MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
FDA Device · Class II · 2022-05-25 · Beckman Coulter - VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - MicroScan WalkAway-96 plus Instrument REF B1018-284
FDA Device · Class II · 2022-05-25 · Beckman Coulter - VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Device · Class II · 2022-05-25 · Beckman Coulter - MicroScan WalkAway-40 plus Instrument REF B1018-283
FDA Device · Class II · 2022-05-25 · Beckman Coulter - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
FDA Device · Class II · 2022-05-25 · Heartware - VITRIGUARD, CARRIER, CLEAR
FDA Device · Class II · 2022-05-25 · Coopersurgical - EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for…
FDA Device · Class II · 2022-05-25 · Boston Scientific - HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
FDA Device · Class II · 2022-05-25 · Heartware - HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
FDA Device · Class II · 2022-05-25 · Heartware - Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports…
FDA Device · Class II · 2022-05-25 · Windstone Medical Packaging - Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a repr…
FDA Device · Class II · 2022-05-25 · Clinician S Choice Dental Products - iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85…
FDA Device · Class I · 2022-05-25 · Atrium Medical - HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
FDA Device · Class II · 2022-05-25 · Heartware - VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Device · Class II · 2022-05-25 · Ortho Clinical Diagnostics - Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
FDA Device · Class II · 2022-05-25 · Luminex - Olympus Uretero-reno videoscope, Model No. URF-V2
FDA Device · Class II · 2022-05-25 · Olympus - HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System E…
FDA Device · Class II · 2022-05-25 · Heartware - Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin
FDA Device · Class II · 2022-05-25 · Radiometer Medical Aps - LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Device · Class II · 2022-05-25 · Smith And Nephew - ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System
FDA Device · Class II · 2022-05-25 · Neuralynx - CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
FDA Device · Class II · 2022-05-25 · Caire - Avanos Cortrak 2 Enteral Access System (EAS)
FDA Device · Class I · 2022-05-25 · Avanos Medical - BF-3C160: EVIS EXERA Bronchovideoscope
FDA Device · Class II · 2022-05-18 · Olympus - Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM0400…
FDA Device · Class II · 2022-05-18 · Medtronic Vascular - 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
FDA Device · Class II · 2022-05-18 · American Contract Systems - Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit
FDA Device · Class I · 2022-05-18 · Woodside Acquisitions - Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement
FDA Device · Class II · 2022-05-18 · Synthes Usa Products - 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - VITEK 2 Systems and VITEK 2 with MYLA
FDA Device · Class II · 2022-05-18 · Biomerieux - CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272…
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
FDA Device · Class II · 2022-05-18 · American Contract Systems - BF-1TQ180: EVIS EXERA II Bronchovideoscope
FDA Device · Class II · 2022-05-18 · Olympus - Accula SARS-CoV-2 Test, REF: COV4100
FDA Device · Class I · 2022-05-18 · Mesa Biotech - 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v
FDA Device · Class II · 2022-05-18 · Daavlin Distributing - 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Uret…
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box
FDA Device · Class II · 2022-05-18 · Certified Safety Mfg - Diagnostic Kit SARS-cCo V Antigen Rapid Test
FDA Device · Class II · 2022-05-18 · Usa Medical - 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - Regard brand CABG Pack A and B - Spartanburg
FDA Device · Class II · 2022-05-18 · Roi Cps - 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - BF-MP160F: EVIS EXERA Bronchofibervideoscope
FDA Device · Class II · 2022-05-18 · Olympus - Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
FDA Device · Class II · 2022-05-18 · Medtronic Vascular - ACS IR - Angio Pack
FDA Device · Class II · 2022-05-18 · American Contract Systems - Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
FDA Device · Class II · 2022-05-18 · Shanghai United Imaging Healthcare - Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient…
FDA Device · Class II · 2022-05-18 · Philips North America - 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
FDA Device · Class I · 2022-05-18 · Woodside Acquisitions - ACS Lap Chole Pack
FDA Device · Class II · 2022-05-18 · American Contract Systems - 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code:…
FDA Device · Class II · 2022-05-18 · Ethicon - ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
FDA Device · Class II · 2022-05-18 · Proterixbio - 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v
FDA Device · Class II · 2022-05-18 · Daavlin Distributing - putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
FDA Device · Class III · 2022-05-18 · Cerapedics - BF-MP60: OES Bronchofiberscope
FDA Device · Class II · 2022-05-18 · Olympus - 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018)
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV
FDA Device · Class II · 2022-05-18 · Karl Storz Endoscopy - ACS Cath Lab Pack
FDA Device · Class II · 2022-05-18 · American Contract Systems - OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
FDA Device · Class II · 2022-05-18 · Simplivia Healthcare - HemosIL ReadiPlasTin, Part No. 0020301400
FDA Device · Class II · 2022-05-18 · Instrumentation Laboratory - TMJ Arthroscopy Drape, 85''x 96''
FDA Device · Class II · 2022-05-18 · Microtek Medical - Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All…
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only
FDA Device · Class II · 2022-05-11 · Johnson And Johnson Surgical Vision - Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging
FDA Device · Class II · 2022-05-11 · Olympus - VELYS Robotic-Assisted Solution Base Product No.: 451570100
FDA Device · Class II · 2022-05-11 · Depuy Orthopaedics - Azurion systems with software release R1.x
FDA Device · Class II · 2022-05-11 · Philips Medical Systems Nederland B V - Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
FDA Device · Class II · 2022-05-11 · Aso - Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
FDA Device · Class I · 2022-05-11 · Sml Distribution - Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage
FDA Device · Class II · 2022-05-11 · Restor3d - Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018)
FDA Device · Class II · 2022-05-11 · Restor3d - Flo-Thru Intraluminal Shunt
FDA Device · Class II · 2022-05-11 · Baxter Healthcare - Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - K-Wire, 1.35 mm x 170 mm
FDA Device · Class II · 2022-05-11 · Arthrex - Restrata, Part Number RWM1-2X2
FDA Device · Class II · 2022-05-11 · Acera Surgical - ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818)
FDA Device · Class II · 2022-05-11 · Restor3d - BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
FDA Device · Class II · 2022-05-11 · Becton Dickinson And - ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lo…
FDA Device · Class II · 2022-05-11 · Siemens Healthcare Diagnostics - Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
FDA Device · Class II · 2022-05-04 · Freudenberg Medical
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)