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.
- Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept…
FDA Device · Class II · 2021-09-15 · Ion Beam Applications - SmartPath to dStream for 1.5T-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 PG, Item No. H78712740000D0, Catalog No. 12740000D
FDA Device · Class II · 2021-09-15 · Angiodynamics - Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501
FDA Device · Class II · 2021-09-15 · Olympus - Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - LiquaSonic Ultrasound Gel 250mL, Model No. 001205
FDA Device · Class I · 2021-09-15 · Athena Medical Products - Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
FDA Device · Class II · 2021-09-15 · Angiodynamics - MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only
FDA Device · Class II · 2021-09-15 · Mivi Neuroscience - Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
FDA Device · Class I · 2021-09-15 · Smiths Medical Asd - Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antige…
FDA Device · Class II · 2021-09-15 · Siemens Healthcare Diagnostics - Pipeline Flex Embolization Device
FDA Device · Class I · 2021-09-15 · Micro Therapeutics - MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length)
FDA Device · Class II · 2021-09-15 · Mivi Neuroscience - EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Device · Class I · 2021-09-15 · Micro Therapeutics - Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01…
FDA Device · Class II · 2021-09-15 · Philips North America - Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 i…
FDA Device · Class II · 2021-09-15 · Siemens Healthcare Diagnostics - Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in…
FDA Device · Class II · 2021-09-15 · Siemens Healthcare Diagnostics - Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is int…
FDA Device · Class II · 2021-09-15 · Nihon Kohden Orangemed - Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-15 · Philips North America - NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
FDA Device · Class I · 2021-09-15 · Smiths Medical Asd - Ingenia 3.0T CX-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 US PG, Item No. H78712740000US0, Catalog No. 12740000US
FDA Device · Class II · 2021-09-15 · Angiodynamics - LiquaSonic Ultrasound Gel 5L, Model No. 001222
FDA Device · Class I · 2021-09-15 · Athena Medical Products - CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein…
FDA Device · Class II · 2021-09-08 · Versea Diagnostics - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
FDA Device · Class II · 2021-09-08 · Covidien - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
FDA Device · Class II · 2021-09-08 · Covidien - Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 108…
FDA Device · Class II · 2021-09-08 · Siemens Medical Solutions Usa - MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Device · Class II · 2021-09-08 · My01 - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
FDA Device · Class II · 2021-09-08 · Covidien - Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies…
FDA Device · Class II · 2021-09-08 · Versea Diagnostics - Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
FDA Device · Class II · 2021-09-08 · Covidien - smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile
FDA Device · Class II · 2021-09-08 · Smiths Medical Asd - Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
FDA Device · Class II · 2021-09-08 · Aspen Surgical Products - Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
FDA Device · Class II · 2021-09-08 · Covidien - TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
FDA Device · Class II · 2021-09-08 · Thera Test Laboratories - Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from C…
FDA Device · Class II · 2021-09-08 · Magnolia Medical Technologies - Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens…
FDA Device · Class II · 2021-09-08 · Versea Diagnostics - Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
FDA Device · Class II · 2021-09-08 · Aspen Surgical Products - EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130
FDA Device · Class II · 2021-09-08 · Thera Test Laboratories - TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Device · Class II · 2021-09-08 · Philips Medical Systems Dmc - Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
FDA Device · Class II · 2021-09-08 · Covidien - Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 1153…
FDA Device · Class II · 2021-09-08 · Baxter Healthcare - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
FDA Device · Class II · 2021-09-08 · Covidien - Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the perform…
FDA Device · Class II · 2021-09-08 · Olympus - Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
FDA Device · Class II · 2021-09-08 · Aspen Surgical Products - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
FDA Device · Class II · 2021-09-08 · Covidien - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
FDA Device · Class II · 2021-09-08 · Zeltiq Aesthetics - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
FDA Device · Class II · 2021-09-08 · Covidien - TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
FDA Device · Class II · 2021-09-08 · Covidien - Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
FDA Device · Class II · 2021-09-08 · Elekta - Merge Hemo, Software packages 10.2, 10.3, and 10.4
FDA Device · Class II · 2021-09-08 · Merge Healthcare - Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
FDA Device · Class II · 2021-09-08 · Covidien - TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to…
FDA Device · Class II · 2021-09-08 · Depuy Orthopaedics - Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
FDA Device · Class II · 2021-09-08 · Clarus Medical - Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
FDA Device · Class II · 2021-09-08 · Covidien - Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
FDA Device · Class II · 2021-09-08 · Covidien - FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous…
FDA Device · Class II · 2021-09-08 · Versea Diagnostics - Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and rena…
FDA Device · Class II · 2021-09-08 · Baxter Healthcare - Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushin…
FDA Device · Class I · 2021-09-01 · Cardinal Health - Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flush…
FDA Device · Class I · 2021-09-01 · Cardinal Health - Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - NES Reprocessed Visions PV .035 IVUS Catheter, Sterile
FDA Device · Class II · 2021-09-01 · Northeast Scientific - KeyPrint Soft- bottle, 32.5 oz (1kg)
FDA Device · Class II · 2021-09-01 · Straumann Usa - Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory infor…
FDA Device · Class II · 2021-09-01 · Beckman Coulter - ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
FDA Device · Class II · 2021-09-01 · Depuy Orthopaedics - Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
FDA Device · Class II · 2021-09-01 · Terumo Cardiovascular Systems - Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2)
FDA Device · Class II · 2021-09-01 · Oakworks - ECHELON MRI System
FDA Device · Class II · 2021-09-01 · Hitachi Healthcare Americas - AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System
FDA Device · Class II · 2021-09-01 · Procept Biorobotics - HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired
FDA Device · Class II · 2021-09-01 · Ethicon Endo Surgery - Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STE…
FDA Device · Class II · 2021-09-01 · W L Gore And Associates - Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2021-09-01 · Philips North America - Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushi…
FDA Device · Class I · 2021-09-01 · Cardinal Health - AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
FDA Device · Class II · 2021-09-01 · Biomimetic Therapeutics - AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev
FDA Device · Class II · 2021-09-01 · Encore Medical
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