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.
- REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1080…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 279…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UD…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 2076300…
FDA Device · Class II · 2021-05-26 · Medtronic - 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for us…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended…
FDA Device · Class II · 2021-05-26 · Medtronic - ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo…
FDA Device · Class II · 2021-05-26 · Boston Scientific - REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for us…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 007630…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 207630…
FDA Device · Class II · 2021-05-26 · Medtronic - VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature
FDA Device · Class I · 2021-05-26 · Boston Scientific - Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763…
FDA Device · Class II · 2021-05-26 · Medtronic - CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is des…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction
FDA Device · Class II · 2021-05-26 · Roche Diagnostics Operations - REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designe…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - 10 GAUGE DRILL, CODE INTVM-DRL
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK…
FDA Device · Class II · 2021-05-26 · Medtronic - RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs
FDA Device · Class II · 2021-05-26 · Raysearch Laboratories Ab - BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 0076300…
FDA Device · Class II · 2021-05-26 · Medtronic - RayStation standalone software radiation therapy treatment planning system
FDA Device · Class II · 2021-05-26 · Raysearch Laboratories Ab - Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)1063009482…
FDA Device · Class II · 2021-05-26 · Bioseal - 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 207630…
FDA Device · Class II · 2021-05-26 · Medtronic - Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL…
FDA Device · Class II · 2021-05-26 · Medtronic - 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - Alpha Interlock Suspension System Lanyard Body: An external prosthetic device
FDA Device · Class II · 2021-05-26 · Willowwood Global - REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, C…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for u…
FDA Device · Class II · 2021-05-26 · Bard Access Systems - Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)0063009443…
FDA Device · Class II · 2021-05-26 · Bioseal - Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
FDA Device · Class II · 2021-05-26 · Bioseal - RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
FDA Device · Class II · 2021-05-26 · Biopsybell S R L - Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are mul…
FDA Device · Class II · 2021-05-26 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for…
FDA Device · Class II · 2021-05-26 · Medtronic - REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vasc…
FDA Device · Class II · 2021-05-19 · Icu Medical - Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screen…
FDA Device · Class II · 2021-05-19 · Remel - REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: prov…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a pati…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vas…
FDA Device · Class II · 2021-05-19 · Icu Medical - AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from…
FDA Device · Class II · 2021-05-19 · Musculoskeletal Transplant Foundation - REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: p…
FDA Device · Class II · 2021-05-19 · Icu Medical - ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide s…
FDA Device · Class I · 2021-05-19 · St Jude Medical Cardian Rhythm Management Division - NM/CT 870 DR Nuclear Medicine / CT Scanners
FDA Device · Class II · 2021-05-19 · Ge Healthcare - REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patien…
FDA Device · Class II · 2021-05-19 · Icu Medical - Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Softwar…
FDA Device · Class II · 2021-05-19 · Meridian Bioscience - REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: pr…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container t…
FDA Device · Class II · 2021-05-19 · Icu Medical - ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intend…
FDA Device · Class II · 2021-05-19 · Argo Medical Technologies - PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801…
FDA Device · Class II · 2021-05-19 · Bard Peripheral Vascular - Regard Dressing Change Tray
FDA Device · Class II · 2021-05-19 · Roi Cps - Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306 - Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306 - REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and pat…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids f…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administr…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the admin…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patien…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the a…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of flui…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a…
FDA Device · Class II · 2021-05-19 · Icu Medical - Kit: LVAD Dres Chg
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306 - NM/CT 860 Nuclear Medicine / CT Scanners
FDA Device · Class II · 2021-05-19 · Ge Healthcare - PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)008017…
FDA Device · Class II · 2021-05-19 · Bard Peripheral Vascular - PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801…
FDA Device · Class II · 2021-05-19 · Bard Peripheral Vascular - ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber o…
FDA Device · Class I · 2021-05-19 · St Jude Medical Cardian Rhythm Management Division - REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provi…
FDA Device · Class II · 2021-05-19 · Icu Medical - VenaSeal Closure System
FDA Device · Class III · 2021-05-19 · Medtronic - REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a…
FDA Device · Class II · 2021-05-19 · Icu Medical - Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator
FDA Device · Class II · 2021-05-19 · Randox Laboratories - Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
FDA Device · Class I · 2021-05-19 · Infusion Pump Repair - Kit: Blood Culture
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306 - REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the admin…
FDA Device · Class II · 2021-05-19 · Icu Medical - AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and ino…
FDA Device · Class II · 2021-05-19 · Fresenius Medical Care Holdings - Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope
FDA Device · Class II · 2021-05-19 · Haag Streit Usa - REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usa…
FDA Device · Class II · 2021-05-19 · Icu Medical - NM/CT 850 Nuclear Medicine / CT Scanners
FDA Device · Class II · 2021-05-19 · Ge Healthcare - NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
FDA Device · Class II · 2021-05-19 · Abbott Laboratories St Jude Medical - Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Device · Class I · 2021-05-19 · Step Har Medical - REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap
FDA Device · Class II · 2021-05-19 · Icu Medical - Kit: Blood Culture MAI Kit Part Number: 80076
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306 - Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run…
FDA Device · Class II · 2021-05-19 · Meridian Bioscience - REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Us…
FDA Device · Class II · 2021-05-19 · Icu Medical - Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac…
FDA Device · Class II · 2021-05-19 · Atos Medical Ab - Kit: Injection REVIEW MAI Kit Part Number: 74736
FDA Device · Class I · 2021-05-19 · Medical Action Industries 306
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)