FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or…
FDA Device · Class II · 2021-09-29 · Argon Medical Devices - Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeo…
FDA Device · Class II · 2021-09-29 · In2bones Usa - Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
FDA Device · Class II · 2021-09-29 · Greiner Bio One North America - Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Aspirated Cyto-Histological Biopsy needle
FDA Device · Class II · 2021-09-29 · M D L S R L - Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100,…
FDA Device · Class I · 2021-09-29 · Amtec Sales - Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - 10 ga ARS Decompression Needle, Part Number ZZ-0298
FDA Device · Class II · 2021-09-29 · North American Rescue - Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom syste…
FDA Device · Class II · 2021-09-29 · Siemens Medical Solutions Usa - Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
FDA Device · Class II · 2021-09-29 · C R Bard - EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7…
FDA Device · Class II · 2021-09-29 · Philips Ultrasound - Soft Tissue Biopsy Needles
FDA Device · Class II · 2021-09-29 · M D L S R L - Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stim…
FDA Device · Class II · 2021-09-29 · Ad Tech Medical Instrument - DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
FDA Device · Class II · 2021-09-29 · Medtronic Perfusion Systems - Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C…
FDA Device · Class II · 2021-09-29 · Beckman Coulter - Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
FDA Device · Class II · 2021-09-29 · Sight Diagnostics - Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultraso…
FDA Device · Class I · 2021-09-29 · Mac Medical Supply - General Manual surgical instrument
FDA Device · Class II · 2021-09-29 · M D L S R L - Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
FDA Device · Class II · 2021-09-29 · Paragon 28 - Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
FDA Device · Class II · 2021-09-29 · C R Bard - Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance…
FDA Device · Class II · 2021-09-29 · Microbiologics - cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
FDA Device · Class II · 2021-09-29 · Roche Molecular Systems - Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Device · Class II · 2021-09-29 · Olympus - Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X…
FDA Device · Class II · 2021-09-29 · Convatec - Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
FDA Device · Class II · 2021-09-29 · C R Bard - Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from var…
FDA Device · Class II · 2021-09-29 · Ge Healthcare - Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
FDA Device · Class II · 2021-09-29 · C R Bard - Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM
FDA Device · Class II · 2021-09-29 · Aesculap Implant Systems - DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
FDA Device · Class II · 2021-09-29 · Medtronic Perfusion Systems - Mammary Nodules Localization
FDA Device · Class II · 2021-09-29 · M D L S R L - Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 79…
FDA Device · Class II · 2021-09-29 · Philips Ultrasound - Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
FDA Device · Class II · 2021-09-29 · C R Bard - Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators
FDA Device · Class II · 2021-09-29 · Ad Tech Medical Instrument - SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performan…
FDA Device · Class II · 2021-09-29 · Microbiologics - BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
FDA Device · Class II · 2021-09-22 · Carefusion - BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012
FDA Device · Class II · 2021-09-22 · Carefusion - BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E
FDA Device · Class II · 2021-09-22 · Carefusion - BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07
FDA Device · Class II · 2021-09-22 · Carefusion - ACUSON Juniper Diagnostic Ultrasound System
FDA Device · Class II · 2021-09-22 · Siemens Medical Solutions Usa - Potassium Hydroxide 10% (KOH 10%), Cat
FDA Device · Class II · 2021-09-22 · Gibson Bioscience - BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
FDA Device · Class II · 2021-09-22 · Carefusion - The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, int…
FDA Device · Class II · 2021-09-22 · Philips North America - Medtronic HVAD Pump Implant Kits
FDA Device · Class II · 2021-09-22 · Heartware - Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
FDA Device · Class I · 2021-09-22 · Cordis - McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
FDA Device · Class II · 2021-09-22 · Cypress Medical Products - BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
FDA Device · Class II · 2021-09-22 · Carefusion - BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031
FDA Device · Class II · 2021-09-22 · Carefusion - MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numb…
FDA Device · Class II · 2021-09-22 · Siemens Medical Solutions Usa - Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10
FDA Device · Class II · 2021-09-22 · Pentax - BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
FDA Device · Class II · 2021-09-22 · Carefusion - BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696
FDA Device · Class II · 2021-09-22 · Carefusion - Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ran…
FDA Device · Class II · 2021-09-22 · Welch Allyn - Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
FDA Device · Class I · 2021-09-22 · Cordis - Verigene EP Amplification Reagent Kit Test
FDA Device · Class II · 2021-09-22 · Luminex - syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go…
FDA Device · Class II · 2021-09-22 · Siemens Medical Solutions Usa - Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use
FDA Device · Class II · 2021-09-22 · Abbott Laboratories - The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app
FDA Device · Class II · 2021-09-22 · Hero Health - BD SmartSite, REF: 2000E CHINA
FDA Device · Class II · 2021-09-22 · Carefusion - AMSORB PLUS PREFILLED G-CAN 1.0L
FDA Device · Class I · 2021-09-22 · Armstrong Medical Services - BD SmartSite Bag Access Device, REF: 2300E-0500
FDA Device · Class II · 2021-09-22 · Carefusion - Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
FDA Device · Class I · 2021-09-22 · Cordis - Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
FDA Device · Class I · 2021-09-22 · Cordis - BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
FDA Device · Class II · 2021-09-22 · Carefusion - Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
FDA Device · Class I · 2021-09-22 · Cordis - Configura Advance Chair, Model Number: CHAIR-0-SC1-030
FDA Device · Class II · 2021-09-22 · Accora - BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511
FDA Device · Class II · 2021-09-22 · Carefusion - Arjo Disposable Repositioning Sling, Model AHD001
FDA Device · Class II · 2021-09-22 · Getinge Dominican Republic - BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
FDA Device · Class II · 2021-09-22 · Leica Microsystems - BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
FDA Device · Class II · 2021-09-22 · Carefusion - Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
FDA Device · Class II · 2021-09-22 · Cellex - The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications,…
FDA Device · Class II · 2021-09-22 · Philips North America - cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
FDA Device · Class II · 2021-09-22 · Roche Diagnostics Operations - Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
FDA Device · Class II · 2021-09-22 · Arjohuntleigh Magog - Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490…
FDA Device · Class II · 2021-09-22 · Pentax - Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124
FDA Device · Class II · 2021-09-22 · Quidel - BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
FDA Device · Class II · 2021-09-22 · Carefusion - The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications,…
FDA Device · Class II · 2021-09-22 · Philips North America - syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Device · Class II · 2021-09-22 · Siemens Medical Solutions Usa - COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples
FDA Device · Class II · 2021-09-15 · Copan Italia - Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
FDA Device · Class II · 2021-09-15 · Angiodynamics
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