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.
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Device · Class II · 2022-07-13 · Chromsystems Instruments And Chemicals - Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
FDA Device · Class I · 2022-07-13 · American Contract Systems - Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion i…
FDA Device · Class II · 2022-07-13 · Depuy Spine - Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Syst…
FDA Device · Class II · 2022-07-06 · Wright Medical Technology - Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
FDA Device · Class II · 2022-07-06 · Fresenius Medical Care Holdings - Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapp…
FDA Device · Class II · 2022-07-06 · Haemonetics - QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C…
FDA Device · Class II · 2022-07-06 · Microgenics - #1 MAC F/O LARYNGOSCOPE
FDA Device · Class II · 2022-07-06 · Baxter Healthcare - regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile
FDA Device · Class II · 2022-07-06 · Roi Cps - DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the…
FDA Device · Class II · 2022-07-06 · Changzhou Biomet Medical Devices - TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
FDA Device · Class II · 2022-07-06 · Haemonetics - System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
FDA Device · Class II · 2022-07-06 · Canon Medical System Usa - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - RayStation 11B
FDA Device · Class II · 2022-07-06 · Raysearch Laboratories Ab - Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
FDA Device · Class II · 2022-07-06 · Skytron Div The Kmw Group - SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (…
FDA Device · Class II · 2022-07-06 · Olympus - VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF…
FDA Device · Class II · 2022-07-06 · Getinge Usa Sales - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
FDA Device · Class II · 2022-07-06 · Dain Technology Subsidiary Of Soundable Health - Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
FDA Device · Class II · 2022-07-06 · Siemens Medical Solutions Usa - Yukon Straight Rod 4.0 x120mm
FDA Device · Class II · 2022-07-06 · K2m - Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anes…
FDA Device · Class II · 2022-07-06 · Ge Healthcare - Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum
FDA Device · Class II · 2022-07-06 · Atrium Medical - Arrow Three-Lumen CVC
FDA Device · Class II · 2022-07-06 · Arrow International - Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
FDA Device · Class II · 2022-07-06 · Ge Healthcare - HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catal…
FDA Device · Class II · 2022-07-06 · Davol - Medline Pill Splitters
FDA Device · Class II · 2022-07-06 · Medline Industries Northfield - NaviCare Nurse Call/Voalte Nurse Call
FDA Device · Class II · 2022-07-06 · Baxter Healthcare - Sensica Urine Output System
FDA Device · Class II · 2022-07-06 · C R Bard - HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing,…
FDA Device · Class II · 2022-07-06 · Davol - BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical curren…
FDA Device · Class II · 2022-06-29 · Beaver Visitec International - Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Device · Class II · 2022-06-29 · New Standard Device - INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen
FDA Device · Class II · 2022-06-29 · Maquet Cardiovascular - Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/RE…
FDA Device · Class I · 2022-06-29 · Getinge Usa Sales - EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenu…
FDA Device · Class II · 2022-06-29 · Olympus - Colonovideoscope Model CF-H180AL
FDA Device · Class II · 2022-06-29 · Olympus - Alcon Clareon IOL with AutonoMe Delivery System
FDA Device · Class II · 2022-06-29 · Alcon Laboratories Ireland - Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/RE…
FDA Device · Class I · 2022-06-29 · Getinge Usa Sales - Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-40…
FDA Device · Class I · 2022-06-29 · Smiths Medical Asd - HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System
FDA Device · Class I · 2022-06-29 · Medtronic - Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 40…
FDA Device · Class I · 2022-06-29 · Smiths Medical Asd - REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO
FDA Device · Class II · 2022-06-29 · Bard Peripheral Vascular - CardioTek EP-TRACER Software V2.x
FDA Device · Class II · 2022-06-29 · Cardiotek Bv - t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
FDA Device · Class II · 2022-06-22 · Tandem Diabetes Care - AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX
FDA Device · Class II · 2022-06-22 · Micro Therapeutics - illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
FDA Device · Class II · 2022-06-22 · Illumina - Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
FDA Device · Class II · 2022-06-22 · Olympus - Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4
FDA Device · Class II · 2022-06-22 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
FDA Device · Class II · 2022-06-22 · Olympus - Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
FDA Device · Class II · 2022-06-22 · Olympus - Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4
FDA Device · Class II · 2022-06-22 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano - Drager SafeStar 55, Catalog No. MP01790
FDA Device · Class I · 2022-06-22 · Draeger Medical - CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001
FDA Device · Class II · 2022-06-22 · Ge Healthcare - illumina Model NextSeq 550 Dx REF 20005715
FDA Device · Class II · 2022-06-22 · Illumina - DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
FDA Device · Class II · 2022-06-15 · Encore Medical - Centricity Cardiology CA1000
FDA Device · Class II · 2022-06-15 · Ge Healthcare - MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to commu…
FDA Device · Class II · 2022-06-15 · Medminder Systems - regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
FDA Device · Class II · 2022-06-15 · Roi Cps - Centricity Enterprise Web
FDA Device · Class II · 2022-06-15 · Ge Healthcare - Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carest…
FDA Device · Class I · 2022-06-15 · Ge Healthcare - HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
FDA Device · Class I · 2022-06-15 · Medtronic - Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
FDA Device · Class II · 2022-06-15 · Roi Cps - Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens
FDA Device · Class II · 2022-06-15 · Siemens Healthcare Diagnostics - Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499)
FDA Device · Class II · 2022-06-15 · Cook - Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and dryin…
FDA Device · Class II · 2022-06-15 · Getinge Usa Sales - Reliance Synergy Washer/Disinfector
FDA Device · Class II · 2022-06-15 · Steris - Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
FDA Device · Class II · 2022-06-15 · Siemens Medical Solutions Usa - GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
FDA Device · Class II · 2022-06-15 · Medacta Usa - AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Device · Class II · 2022-06-15 · Northgate Technologies - Triathlon Tritanium Tibial Component (Size 6)
FDA Device · Class II · 2022-06-15 · Howmedica Osteonics - Oakworks Bed (Emergency Field Bed)
FDA Device · Class II · 2022-06-15 · Oakworks - Centricity PACS RA1000
FDA Device · Class II · 2022-06-15 · Ge Healthcare - Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Device · Class II · 2022-06-15 · Siemens Medical Solutions Usa - Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-0…
FDA Device · Class II · 2022-06-15 · Cook - V8 Immunodisplacement Kit REF 1803
FDA Device · Class II · 2022-06-15 · Helena Laboratories - 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
FDA Device · Class II · 2022-06-15 · New Standard Device - PX200 Emergency Relief Bed
FDA Device · Class II · 2022-06-15 · Oakworks - (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with comp…
FDA Device · Class II · 2022-06-15 · Bsn Medical - NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
FDA Device · Class II · 2022-06-15 · Neumodx Molecular - Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgica…
FDA Device · Class II · 2022-06-15 · Getinge Usa Sales - Centricity Radiology RA600
FDA Device · Class II · 2022-06-15 · Ge Healthcare - STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R…
FDA Device · Class II · 2022-06-15 · Karl Storz Endoscopy - Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Mat…
FDA Device · Class II · 2022-06-15 · Siemens Healthcare Diagnostics - Centricity Universal Viewer Zero Footprint Client
FDA Device · Class II · 2022-06-15 · Ge Healthcare - Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
FDA Device · Class II · 2022-06-15 · Siemens Medical Solutions Usa - Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators
FDA Device · Class I · 2022-06-15 · Ge Healthcare - Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2…
FDA Device · Class II · 2022-06-15 · Cook - 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - APD Drain Manifold
FDA Device · Class II · 2022-06-08 · Baxter Healthcare - Nerve Block Tray Catalog Number: 3764R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - FIRMap" Catheter, 60mm Basket
FDA Device · Class II · 2022-06-08 · Abbott - Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - BD Anti-Kappa PE (Cat
FDA Device · Class II · 2022-06-08 · Becton Dickinson And Bd Biosciences - SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
FDA Device · Class II · 2022-06-08 · Medline Industries Northfield - Effluent Sample Bag
FDA Device · Class II · 2022-06-08 · Baxter Healthcare
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