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.
- Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Device · Class II · 2021-10-13 · Beckman Coulter - CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
FDA Device · Class II · 2021-10-13 · Cardioquip - Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
FDA Device · Class II · 2021-10-13 · Zoll Circulation - OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX
FDA Device · Class II · 2021-10-13 · Exactech - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-…
FDA Device · Class II · 2021-10-13 · Datascope - ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabil…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices
FDA Device · Class II · 2021-10-13 · Cardioquip - ARCH Leg Positioning System
FDA Device · Class II · 2021-10-13 · Innovative Orthopedic Technologies - Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampou…
FDA Device · Class II · 2021-10-13 · Contamac Solutions - REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
FDA Device · Class II · 2021-10-13 · Bard Peripheral Vascular - Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPAR…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - Ultra-Myossage Lotion 1-gallon bottle, REF: 4262
FDA Device · Class I · 2021-10-13 · Djo - Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infu…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components
FDA Device · Class II · 2021-10-13 · Exactech - Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens),…
FDA Device · Class II · 2021-10-13 · Zoll Circulation - GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the follo…
FDA Device · Class I · 2021-10-13 · Djo - Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral flui…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pare…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off
FDA Device · Class II · 2021-10-06 · B Braun Medical - BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
FDA Device · Class II · 2021-10-06 · Olympus - Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL
FDA Device · Class I · 2021-10-06 · North Coast Medical - Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System
FDA Device · Class II · 2021-10-06 · Corin - Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only…
FDA Device · Class I · 2021-10-06 · Imperative Care - 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for i…
FDA Device · Class II · 2021-10-06 · B Braun Medical - 15 drops/ml, Priming Volume: 27ml, Length: 129 in
FDA Device · Class II · 2021-10-06 · B Braun Medical - LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity du…
FDA Device · Class II · 2021-10-06 · Hill Rom - OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during…
FDA Device · Class II · 2021-10-06 · Hill Rom - BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
FDA Device · Class II · 2021-10-06 · Olympus - NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Por…
FDA Device · Class II · 2021-10-06 · Medline Industries - GENOSYL DS (Delivery System) console, for use as a vasodilator
FDA Device · Class I · 2021-10-06 · Vero Biotech - Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…
FDA Device · Class II · 2021-10-06 · B Braun Medical - BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
FDA Device · Class II · 2021-10-06 · Olympus - Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339
FDA Device · Class II · 2021-10-06 · Ge Healthcare - DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Device · Class II · 2021-10-06 · Beckman Coulter - Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile
FDA Device · Class II · 2021-10-06 · Corin - V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee…
FDA Device · Class II · 2021-10-06 · Corin - DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
FDA Device · Class II · 2021-10-06 · Convatec - BF-N20 OES Bronchofiberscope, Model No. BF-N20
FDA Device · Class II · 2021-10-06 · Olympus - Omnisound Gel, 250 ml bottle and 5 L container
FDA Device · Class I · 2021-10-06 · Accelerated Care Plus - OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion o…
FDA Device · Class II · 2021-10-06 · B Braun Medical - ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parent…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile
FDA Device · Class II · 2021-10-06 · Corin - uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localiza…
FDA Device · Class II · 2021-10-06 · Shanghai United Imaging Healthcare - Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330
FDA Device · Class II · 2021-10-06 · Biodex Medical Systems - Atrium Pneumostat Chest Drain Valve, Part Number 16100
FDA Device · Class II · 2021-10-06 · Atrium Medical - FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during…
FDA Device · Class II · 2021-10-06 · Hill Rom - Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
FDA Device · Class II · 2021-10-06 · Wom World - uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, dia…
FDA Device · Class II · 2021-10-06 · Shanghai United Imaging Healthcare - DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA Device · Class I · 2021-10-06 · Deroyal Industries Lafollette - Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction…
FDA Device · Class II · 2021-10-06 · Atrium Medical - BF-P60 OES Bronchofiberscope, Model No. BF-P60
FDA Device · Class II · 2021-10-06 · Olympus - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-…
FDA Device · Class II · 2021-10-06 · Datascope - OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2021-10-06 · Elekta - Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horiz…
FDA Device · Class II · 2021-10-06 · B Braun Medical - PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Device · Class II · 2021-10-06 · Aesculap Implant Systems - The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches
FDA Device · Class II · 2021-10-06 · Vascutek - Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG…
FDA Device · Class II · 2021-10-06 · Ge Healthcare - Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0
FDA Device · Class II · 2021-10-06 · Arjohuntleigh Polska Sp Z O O - Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion Sy…
FDA Device · Class II · 2021-10-06 · B Braun Medical - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Device · Class II · 2021-10-06 · Aesculap Implant Systems - NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, S…
FDA Device · Class II · 2021-10-06 · Medline Industries - OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pa…
FDA Device · Class II · 2021-10-06 · B Braun Medical - BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
FDA Device · Class II · 2021-10-06 · Olympus - BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
FDA Device · Class II · 2021-10-06 · Olympus - 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump fo…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head,…
FDA Device · Class II · 2021-10-06 · Corin - The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifur…
FDA Device · Class II · 2021-10-06 · Vascutek - MOSAIQ Oncology Information System
FDA Device · Class II · 2021-10-06 · Elekta - Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System
FDA Device · Class II · 2021-10-06 · Corin - VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Device · Class II · 2021-10-06 · Greiner Bio One North America - Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13…
FDA Device · Class II · 2021-10-06 · Abbott Molecular - BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
FDA Device · Class II · 2021-10-06 · Olympus - OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral…
FDA Device · Class II · 2021-10-06 · B Braun Medical - BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
FDA Device · Class II · 2021-10-06 · Olympus - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2021-10-06 · Datascope - Xcela PICC with PASV Valve Technology/Kit 5 F-55cm
FDA Device · Class II · 2021-10-06 · Angiodynamics Navilyst Medical - AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
FDA Device · Class II · 2021-10-06 · Biodex Medical Systems - Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular S…
FDA Device · Class II · 2021-10-06 · Corin - AMX Navigate Mobile X-Ray System
FDA Device · Class II · 2021-10-06 · Ge Healthcare - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT P…
FDA Device · Class II · 2021-10-06 · B Braun Medical - LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combinati…
FDA Device · Class II · 2021-10-06 · Hill Rom - Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile
FDA Device · Class II · 2021-10-06 · Corin - Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/o…
FDA Device · Class II · 2021-10-06 · B Braun Medical - Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile
FDA Device · Class II · 2021-10-06 · Corin - BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
FDA Device · Class II · 2021-10-06 · Olympus - EcoLotion Transmission Lotion, used in ultrasound procedures
FDA Device · Class I · 2021-10-06 · North Coast Medical - Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
FDA Device · Class II · 2021-10-06 · Deerfield Imaging - Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
FDA Device · Class II · 2021-10-06 · Corin - Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity du…
FDA Device · Class II · 2021-10-06 · Hill Rom - LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2…
FDA Device · Class II · 2021-10-06 · Lymol Medical - Bone Marrow Transplantation biopsy needle
FDA Device · Class II · 2021-09-29 · M D L S R L - Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard - Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulato…
FDA Device · Class II · 2021-09-29 · Ad Tech Medical Instrument - Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from v…
FDA Device · Class II · 2021-09-29 · Ge Healthcare - Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
FDA Device · Class II · 2021-09-29 · C R Bard
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)