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.
- Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no
FDA Device · Class II · 2021-08-04 · Innovative Tomography Product - SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm La…
FDA Device · Class II · 2021-07-28 · Exactech - The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock c…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10
FDA Device · Class I · 2021-07-28 · Respironics California - Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
FDA Device · Class II · 2021-07-28 · Cell Marque - SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or…
FDA Device · Class II · 2021-07-28 · Soft Computer Consultants - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral…
FDA Device · Class II · 2021-07-28 · Exactech - 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Tele…
FDA Device · Class III · 2021-07-28 · Mindray Ds Usa - Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialys…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home se…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Medtronic Reveal LINQ LNQ11 / PA96000
FDA Device · Class II · 2021-07-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG an…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm La…
FDA Device · Class II · 2021-07-28 · Exactech - Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by…
FDA Device · Class II · 2021-07-28 · Cardinal Health 200 - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG an…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Line…
FDA Device · Class II · 2021-07-28 · Exactech - 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Device · Class II · 2021-07-28 · Randox Laboratories - Stimulen Collagen Moisturizing Lotion, ST9555B
FDA Device · Class II · 2021-07-28 · Southwest Technologies - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner,…
FDA Device · Class II · 2021-07-28 · Exactech - Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
FDA Device · Class II · 2021-07-28 · Stryker Spine - The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count
FDA Device · Class II · 2021-07-28 · Medline Industries - (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end sta…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the adm…
FDA Device · Class II · 2021-07-28 · Mckesson Medical Surgical Corporate Office - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm La…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm La…
FDA Device · Class II · 2021-07-28 · Exactech - Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, produ…
FDA Device · Class II · 2021-07-28 · Dutch Ophthalmic Usa - Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10
FDA Device · Class I · 2021-07-28 · Respironics California - Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003…
FDA Device · Class II · 2021-07-28 · Caption Health - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped…
FDA Device · Class II · 2021-07-28 · Exactech - Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation o…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22…
FDA Device · Class II · 2021-07-28 · Exactech - DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
FDA Device · Class II · 2021-07-28 · Encore Medical - Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Device · Class II · 2021-07-28 · Dutch Ophthalmic Usa - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner,…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner…
FDA Device · Class II · 2021-07-28 · Exactech - Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022
FDA Device · Class II · 2021-07-28 · Gentherm Medical - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG an…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg…
FDA Device · Class II · 2021-07-28 · Exactech - Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
FDA Device · Class II · 2021-07-28 · Arthrex - Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care…
FDA Device · Class II · 2021-07-28 · Cardinal Health 200 - Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
FDA Device · Class II · 2021-07-28 · Stryker Spine - The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
FDA Device · Class II · 2021-07-28 · Encore Medical - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm La…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner…
FDA Device · Class II · 2021-07-28 · Exactech - AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen…
FDA Device · Class II · 2021-07-28 · Mediana - SoftCytogenetics
FDA Device · Class II · 2021-07-28 · Soft Computer Consultants - NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysat…
FDA Device · Class II · 2021-07-28 · Fresenius Medical Care Holdings - Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
FDA Device · Class II · 2021-07-28 · Cell Marque - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Line…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner…
FDA Device · Class II · 2021-07-28 · Exactech - Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Line…
FDA Device · Class II · 2021-07-28 · Exactech - DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, No…
FDA Device · Class I · 2021-07-21 · Philips Respironics - Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imagin…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa - Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover
FDA Device · Class II · 2021-07-21 · Owen Mumford Usa - Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise…
FDA Device · Class II · 2021-07-21 · Ge Healthcare - Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cro…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa - Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduc…
FDA Device · Class II · 2021-07-21 · Cordis - Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in el…
FDA Device · Class II · 2021-07-21 · Arrow International - EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar
FDA Device · Class II · 2021-07-21 · Baxter Healthcare - SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
FDA Device · Class II · 2021-07-21 · Ge Healthcare - Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box
FDA Device · Class II · 2021-07-21 · Mercedes Medical - SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio,…
FDA Device · Class II · 2021-07-21 · Ge Healthcare - Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack
FDA Device · Class II · 2021-07-21 · Mercedes Medical - Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiol…
FDA Device · Class II · 2021-07-21 · Arrow International - SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Device · Class I · 2021-07-21 · Boston Scientific - Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
FDA Device · Class I · 2021-07-21 · Philips Respironics - Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use
FDA Device · Class I · 2021-07-21 · Philips Respironics - Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironic…
FDA Device · Class I · 2021-07-21 · Philips Respironics - SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Device · Class II · 2021-07-21 · C Rad Positioning Ab - SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio,…
FDA Device · Class II · 2021-07-21 · Ge Healthcare - Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for…
FDA Device · Class II · 2021-07-21 · Arrow International - SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio…
FDA Device · Class II · 2021-07-21 · Ge Healthcare - EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover
FDA Device · Class II · 2021-07-21 · Implantcast - INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Device · Class I · 2021-07-21 · Boston Scientific - INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Device · Class I · 2021-07-21 · Boston Scientific - Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
FDA Device · Class II · 2021-07-21 · Rand S R L - Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, F…
FDA Device · Class II · 2021-07-21 · Tornier - INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Device · Class I · 2021-07-21 · Boston Scientific - Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099
FDA Device · Class II · 2021-07-21 · Rand S R L - Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coron…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa - Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended fo…
FDA Device · Class II · 2021-07-21 · Arrow International - Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces…
FDA Device · Class II · 2021-07-21 · Canon Medical System Usa - SIGNA MR380, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - SIGNA Artist, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare - HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory le…
FDA Device · Class II · 2021-07-21 · Heartware - A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
FDA Device · Class I · 2021-07-21 · Philips Respironics - Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
FDA Device · Class II · 2021-07-21 · Medtronic Cardiac Rhythm And Heart Failure Crhf - VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f)…
FDA Device · Class I · 2021-07-21 · Boston Scientific - SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2021-07-21 · Ge Healthcare
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)