FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to…
FDA Device · Class II · 2017-06-14 · Arrow International - Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal…
FDA Device · Class II · 2017-06-14 · Arrow International - DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
FDA Device · Class II · 2017-06-14 · Depuy Orthopaedics - Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Tech…
FDA Device · Class II · 2017-06-14 · Arrow International - AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circula…
FDA Device · Class II · 2017-06-14 · Arrow International - Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E
FDA Device · Class II · 2017-06-14 · Convatec - Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral a…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety…
FDA Device · Class II · 2017-06-14 · Arrow International - Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
FDA Device · Class II · 2017-06-14 · Convatec - Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommend…
FDA Device · Class II · 2017-06-14 · Orthopediatrics - Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
FDA Device · Class II · 2017-06-14 · Convatec - Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
FDA Device · Class II · 2017-06-14 · Convatec - Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook - Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
FDA Device · Class II · 2017-06-14 · Convatec - ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) centr…
FDA Device · Class II · 2017-06-14 · Arrow International - AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the fe…
FDA Device · Class II · 2017-06-07 · Zimmer Biomet - The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training
FDA Device · Class II · 2017-06-07 · Acumed - Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a ran…
FDA Device · Class III · 2017-06-07 · Randox Laboratories - Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
FDA Device · Class II · 2017-06-07 · Madison Polymeric Engineering - Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
FDA Device · Class II · 2017-06-07 · Arrow International - Adenovirus (20/11 & 2/6)
FDA Device · Class II · 2017-06-07 · Cell Marque - Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28
FDA Device · Class II · 2017-06-07 · Cell Marque - Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
FDA Device · Class II · 2017-06-07 · Toshiba American Medical Systems - NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
FDA Device · Class II · 2017-06-07 · Philips Electronics North America - Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basi…
FDA Device · Class III · 2017-06-07 · Acumedia Manufacturers - AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
FDA Device · Class II · 2017-06-07 · Abbvie - Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture me…
FDA Device · Class III · 2017-06-07 · Acumedia Manufacturers - AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
FDA Device · Class II · 2017-06-07 · Abbvie - Reusable instruments in the Knee, Hip, Trauma, and Extremities segments
FDA Device · Class II · 2017-06-07 · Zimmer Biomet - Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18
FDA Device · Class II · 2017-06-07 · Cell Marque - HHV-8 (13810)
FDA Device · Class II · 2017-06-07 · Cell Marque - Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Rea…
FDA Device · Class II · 2017-06-07 · Cell Marque - CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use…
FDA Device · Class II · 2017-06-07 · Cell Marque - Her2/Neu (c-erbB-2) (CB-1 1)
FDA Device · Class II · 2017-06-07 · Cell Marque - H. pylori (polyclonal} 1.0 mL Catalog number 215A-76
FDA Device · Class II · 2017-06-07 · Cell Marque - Her2/Neu (EP3)
FDA Device · Class II · 2017-06-07 · Cell Marque - Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
FDA Device · Class II · 2017-06-07 · Ethicon Endo Surgery - Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized w…
FDA Device · Class III · 2017-06-07 · Acumedia Manufacturers - AIA-PACK TgAb CONTROL SET
FDA Device · Class III · 2017-06-07 · Tosoh Bioscience - Elecsys PreciControl Varia 3
FDA Device · Class II · 2017-06-07 · Roche Diagnostics - Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
FDA Device · Class II · 2017-06-07 · Ge Healthcare - Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia)
FDA Device · Class I · 2017-06-07 · Abbott Vascular - Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use
FDA Device · Class II · 2017-06-07 · Exact Sciences - AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
FDA Device · Class II · 2017-06-07 · Abbvie - Assist Bed Rail - 6632
FDA Device · Class II · 2017-06-07 · Invacare - SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurem…
FDA Device · Class II · 2017-06-07 · Siemens Healthcare Diagnostics - 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5)
FDA Device · Class II · 2017-06-07 · Kci Usa - Herpes Simplex Virus I
FDA Device · Class II · 2017-06-07 · Cell Marque - Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
FDA Device · Class II · 2017-06-07 · Cardinal Scale Mfg - SV40 (MRQ-4) 0.5 ml catalog number 351 M-15
FDA Device · Class II · 2017-06-07 · Cell Marque - AIA-PACK TPOAb CONTROL SET
FDA Device · Class III · 2017-06-07 · Tosoh Bioscience - Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sea…
FDA Device · Class II · 2017-06-07 · Zimmer Biomet - Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnosti…
FDA Device · Class II · 2017-06-07 · Hans Pausch Rontgengeratebau - Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572
FDA Device · Class II · 2017-06-07 · Medtest Holdings - Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagn…
FDA Device · Class II · 2017-06-07 · Cell Marque - Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide
FDA Device · Class II · 2017-06-07 · Vascular Solutions - AXIOM Sensis, Computer, Diagnostic, Programmable
FDA Device · Class II · 2017-05-31 · Siemens Medical Solutions Usa - CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm)
FDA Device · Class II · 2017-05-31 · Corpak Medsystems - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml)
FDA Device · Class II · 2017-05-31 · Mesa Laboratories - Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimi…
FDA Device · Class II · 2017-05-31 · Biomerieux - Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
FDA Device · Class II · 2017-05-31 · Implant Direct Sybron Manufacturing - UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322
FDA Device · Class II · 2017-05-31 · Beckman Coulter - Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag
FDA Device · Class II · 2017-05-31 · Innovasis - Merge Cardio software
FDA Device · Class II · 2017-05-31 · Merge Healthcare - PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
FDA Device · Class II · 2017-05-31 · Teleflex Medical - Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the s…
FDA Device · Class II · 2017-05-31 · Corpak Medsystems - StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile
FDA Device · Class II · 2017-05-31 · Bard Access Systems - Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
FDA Device · Class II · 2017-05-31 · Beckman Coulter - Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
FDA Device · Class II · 2017-05-31 · Medtronic Cardiac Rhythm And Heart Failure - 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator
FDA Device · Class I · 2017-05-31 · Ebi Patient Care - Jackson-Pratt Hemaduct Silicone Flat Drain
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2017-05-31 · Cardiovascular Systems - Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended f…
FDA Device · Class II · 2017-05-31 · Stryker Howmedica Osteonics - PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
FDA Device · Class II · 2017-05-31 · Teleflex Medical - Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR
FDA Device · Class II · 2017-05-31 · Corpak Medsystems - Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s)…
FDA Device · Class II · 2017-05-31 · Beckman Coulter - Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
FDA Device · Class II · 2017-05-31 · B Braun Medical - Jackson-Pratt PVC Round Drain, 10FR W/Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - HeartMate¿ II LVAS with Pocket Controller
FDA Device · Class I · 2017-05-31 · Thoratec - Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a card…
FDA Device · Class II · 2017-05-31 · Datascope - Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - 10-1398M - SpF-PLUS Implantable Stimulator
FDA Device · Class I · 2017-05-31 · Ebi Patient Care
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)