FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnost…
FDA Device · Class II · 2018-05-23 · Visaris Doo - Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Kelyniam Custom Skull Implant (CSI), Model no
FDA Device · Class II · 2018-05-23 · Kelyniam Global - KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
FDA Device · Class II · 2018-05-23 · Siemens Medical Solutions Usa - Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) Product Usage: The Endo GIA…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality c…
FDA Device · Class II · 2018-05-23 · Tosoh Bioscience - 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
FDA Device · Class II · 2018-05-23 · Ethicon Endo Surgery - (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSL…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014…
FDA Device · Class I · 2018-05-23 · Micro Therapeutics - Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis
FDA Device · Class II · 2018-05-23 · Zimmer Biomet - BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan M…
FDA Device · Class II · 2018-05-23 · Beckman Coulter - Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis
FDA Device · Class II · 2018-05-23 · Zimmer Biomet - (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, K…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titani…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - RICHARD WOLF TUBE SET FOR TEM, REF 4170.801
FDA Device · Class II · 2018-05-23 · Richard Wolf - 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
FDA Device · Class II · 2018-05-23 · Ethicon Endo Surgery - (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKT…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm…
FDA Device · Class II · 2018-05-23 · Convatec - Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnost…
FDA Device · Class II · 2018-05-23 · Visaris Doo - BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows o…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) Product Usage: The Endo GIA universal and Endo G…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis
FDA Device · Class II · 2018-05-23 · Zimmer Biomet - Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
FDA Device · Class II · 2018-05-23 · Epic Extremity - Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis
FDA Device · Class II · 2018-05-23 · Zimmer Biomet - BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagger…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
FDA Device · Class II · 2018-05-23 · Ethicon Endo Surgery - Kelyniam Custom Skull Implant (CSI), Model no
FDA Device · Class II · 2018-05-23 · Kelyniam Global - Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measure…
FDA Device · Class II · 2018-05-23 · Tosoh Bioscience - (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) Product Usage: The Endo GIA universal and Endo…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo G…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagger…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagn…
FDA Device · Class II · 2018-05-23 · Beckman Coulter - Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
FDA Device · Class II · 2018-05-23 · Micro Tech Nanjing - SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
FDA Device · Class II · 2018-05-23 · Siemens Medical Solutions Usa - Fischer Cone Biopsy Excisor, Medium (5/Box)
FDA Device · Class II · 2018-05-23 · Coopersurgical - MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Kelyniam Custom Skull Implant (CSI), Model no
FDA Device · Class II · 2018-05-23 · Kelyniam Global - (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 Pr…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
FDA Device · Class II · 2018-05-23 · Siemens Medical Solutions Usa - BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered row…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014
FDA Device · Class II · 2018-05-23 · Bard Peripheral Vascular - BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-st…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only
FDA Device · Class II · 2018-05-23 · Volcano - BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of t…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be use…
FDA Device · Class II · 2018-05-23 · Rockwell Medical - (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-s…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo G…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titan…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
FDA Device · Class II · 2018-05-23 · Epic Extremity - BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagger…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal interverte…
FDA Device · Class II · 2018-05-16 · Medtronic Sofamor Danek Usa - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Straumann¿ Emdogain 0.3 ml Multipack
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
FDA Device · Class II · 2018-05-16 · Cook - AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resus…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
FDA Device · Class III · 2018-05-16 · Siemens Healthcare Diagnostics - ZYMUTEST HIA IgGAM
FDA Device · Class II · 2018-05-16 · Hyphen Biomed - Syngo.Via VB20A model 1049610
FDA Device · Class II · 2018-05-16 · Siemens Medical Solutions Usa - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: T…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - Straumann¿ Emdogain 0.7 ml Multipack
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump w…
FDA Device · Class II · 2018-05-16 · Baxter Healthcare - Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating,…
FDA Device · Class I · 2018-05-16 · Draeger Medical - IMMULITE ¿ /IMMULITE ¿ 1000 CEA
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resus…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
FDA Device · Class II · 2018-05-16 · Cook - Dimension Vista Glucose (GLU) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
FDA Device · Class II · 2018-05-16 · Datascope - PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
FDA Device · Class II · 2018-05-16 · Datascope - PFR Kit- Pinnacle, Anterior Apical
FDA Device · Class II · 2018-05-16 · Boston Scientific - Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump…
FDA Device · Class II · 2018-05-16 · Baxter Healthcare - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual res…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
FDA Device · Class II · 2018-05-16 · Datascope - ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (hepar…
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscita…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Capio RP
FDA Device · Class II · 2018-05-16 · Boston Scientific
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)