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.
- Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer…
FDA Device · Class II · 2017-12-27 · Zimmer Dental - Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130…
FDA Device · Class II · 2017-12-27 · Terumo Cardiovascular Systems - ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria s…
FDA Device · Class II · 2017-12-27 · Biomerieux - Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2017-12-27 · Philips Electronics North America - Tapered Screw-Vent MTX Model TSVTB11
FDA Device · Class II · 2017-12-27 · Zimmer Dental - I-125 CE Marked QuickLink Cartridges
FDA Device · Class II · 2017-12-27 · C R Bard - Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) all…
FDA Device · Class II · 2017-12-27 · Implant Direct Sybron Manufacturing - Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm
FDA Device · Class II · 2017-12-27 · Stryker Neurovascular - TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
FDA Device · Class II · 2017-12-27 · Terumo Cardiovascular Systems - Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm
FDA Device · Class II · 2017-12-27 · Stryker Neurovascular - Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Ma…
FDA Device · Class II · 2017-12-27 · Zimmer Dental - Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is M…
FDA Device · Class II · 2017-12-27 · Zimmer Dental - Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on hu…
FDA Device · Class II · 2017-12-27 · Philips Electronics North America - Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads
FDA Device · Class II · 2017-12-27 · C R Bard - QIAamp DSP Virus Kit Cat
FDA Device · Class II · 2017-12-27 · Qiagen - 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector
FDA Device · Class II · 2017-12-27 · Stryker Sustainability Solutions - The GMK knee system: designed for cemented use in total knee arthroplasty
FDA Device · Class II · 2017-12-27 · Medacta Usa - Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Micr…
FDA Device · Class II · 2017-12-27 · Stryker Neurovascular - Zimmer Dental GemLock RHD2.5 Hex Driver
FDA Device · Class II · 2017-12-27 · Zimmer Dental - ExploR Radial Head Replacement System
FDA Device · Class II · 2017-12-27 · Zimmer Biomet - Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility
FDA Device · Class III · 2017-12-27 · Philips Electronics North America - Xper Flex Cardio Physiomonitoring system
FDA Device · Class II · 2017-12-27 · Invivo - Rezum System, Vapor BPH Ablation System, Model Number D2201-003
FDA Device · Class II · 2017-12-27 · Nxthera - ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria s…
FDA Device · Class II · 2017-12-27 · Biomerieux - Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The X…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - enGen Track System with TCAutomation Software Version 4.2
FDA Device · Class II · 2017-12-20 · Ortho Clinical Diagnostics - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
FDA Device · Class II · 2017-12-20 · Beckman Coulter - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America - Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments
FDA Device · Class II · 2017-12-20 · Elekta - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
FDA Device · Class II · 2017-12-20 · Beckman Coulter - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXP…
FDA Device · Class I · 2017-12-20 · Physio Control - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - BLUE BURN SHEET, STERILE, 60" x 96"
FDA Device · Class II · 2017-12-20 · Dukal - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is…
FDA Device · Class II · 2017-12-20 · Beckman Coulter - XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technolog…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Tech…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Techno…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRES…
FDA Device · Class I · 2017-12-20 · Physio Control - XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - United Nuclear Scientific High Power Handheld Lasers
FDA Device · Class II · 2017-12-20 · United Nuclear Scientific Supplies - Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of t…
FDA Device · Class II · 2017-12-20 · Amendia - Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and…
FDA Device · Class II · 2017-12-20 · Angiodynamics Navilyst Medical - FUJIFILM FDR Visionary Suite with CH-200
FDA Device · Class II · 2017-12-20 · Fujifilm Medical Systems U - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) co…
FDA Device · Class II · 2017-12-20 · Normand Informatique - Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
FDA Device · Class II · 2017-12-20 · Terumo Medical - Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthros…
FDA Device · Class II · 2017-12-20 · Conmed - Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by seve…
FDA Device · Class II · 2017-12-13 · Exactech - Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc
FDA Device · Class II · 2017-12-13 · Exactech - ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01
FDA Device · Class II · 2017-12-13 · Icu Medical - Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression
FDA Device · Class II · 2017-12-13 · Won Industry - Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pedia…
FDA Device · Class II · 2017-12-13 · Intersurgical - BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standar…
FDA Device · Class III · 2017-12-13 · Becton Dickinson And - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster - Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for singl…
FDA Device · Class II · 2017-12-13 · Novo Nordisk - Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Mo…
FDA Device · Class II · 2017-12-13 · Fukuda Denshi - SMARTABLATE RF System Generator
FDA Device · Class II · 2017-12-13 · Biosense Webster - BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspirati…
FDA Device · Class II · 2017-12-13 · Becton Dickinson And - Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / G…
FDA Device · Class II · 2017-12-13 · Roche Diabetes Care - CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is i…
FDA Device · Class II · 2017-12-13 · Ge Medical Systems Information Technologies - CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres
FDA Device · Class II · 2017-12-13 · Remel - Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
FDA Device · Class III · 2017-12-13 · C R Bard - PENTARAY NAV High-Density Mapping Catheter
FDA Device · Class II · 2017-12-13 · Biosense Webster - pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY T…
FDA Device · Class II · 2017-12-13 · Pro Med Instruments - TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cult…
FDA Device · Class II · 2017-12-13 · Becton Dickinson And - DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision…
FDA Device · Class II · 2017-12-13 · Deroyal Industries - Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage util…
FDA Device · Class II · 2017-12-13 · Won Industry - Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716
FDA Device · Class II · 2017-12-06 · Siemens Healthcare Diagnostics - BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST…
FDA Device · Class II · 2017-12-06 · Becton Dickinson And - ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical proce…
FDA Device · Class II · 2017-12-06 · Implant Direct Sybron Manufacturing - BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3…
FDA Device · Class II · 2017-12-06 · Brainlab Ag - ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central…
FDA Device · Class II · 2017-12-06 · Arrow International - Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic…
FDA Device · Class II · 2017-12-06 · Medtronic - ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or l…
FDA Device · Class II · 2017-12-06 · Arrow International - Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability)
FDA Device · Class II · 2017-12-06 · Hill Rom Manufacturing - ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm
FDA Device · Class II · 2017-12-06 · Zimmer Biomet - Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console…
FDA Device · Class II · 2017-12-06 · Arrow International - Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US)…
FDA Device · Class II · 2017-12-06 · Siemens Healthcare Diagnostics - SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Device · Class II · 2017-12-06 · Csl Behring
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)