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.
- ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit
FDA Device · Class II · 2018-06-06 · Arrow International - VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref
FDA Device · Class II · 2018-06-06 · Maquet Sas - nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not li…
FDA Device · Class II · 2018-06-06 · Nordicneurolab As - Echogenic Introducer Needle
FDA Device · Class II · 2018-06-06 · Arrow International - Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - SnapLock" Catheter/Syringe Adapter
FDA Device · Class II · 2018-06-06 · Arrow International - ARROWg+ard Blue(R) Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage…
FDA Device · Class II · 2018-06-06 · Medline Industries - 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneo…
FDA Device · Class II · 2018-06-06 · Arrow International - VPS Rhythm ECG Accessory Pack
FDA Device · Class II · 2018-06-06 · Arrow International - Radial Artery Catheterization Kit with Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit
FDA Device · Class II · 2018-06-06 · Arrow International - 0.2 Micron Flat Epidural Filter
FDA Device · Class II · 2018-06-06 · Arrow International - Epidural Needle
FDA Device · Class II · 2018-06-06 · Arrow International - Spring-Wire Guide Introducer Catheter Assembly
FDA Device · Class II · 2018-06-06 · Arrow International - Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions
FDA Device · Class II · 2018-06-06 · Arrow International - MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be u…
FDA Device · Class II · 2018-06-06 · Medline Industries - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Fe…
FDA Device · Class II · 2018-06-06 · Arrow International - Respire Pink+ Hard Oral Sleep Apnea Device
FDA Device · Class II · 2018-06-06 · Respire Medical - 4Fr. Catheter Clamp with Fastener
FDA Device · Class II · 2018-06-06 · Arrow International - Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG)
FDA Device · Class II · 2018-06-06 · Arrow International - Respire Pink Series EF+ Oral Sleep Apnea Device
FDA Device · Class II · 2018-06-06 · Respire Medical - ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter
FDA Device · Class II · 2018-06-06 · Arrow International - Maximal Barrier Drape
FDA Device · Class II · 2018-06-06 · Arrow International - Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety…
FDA Device · Class II · 2018-06-06 · Arrow International - 5Fr. Catheter Clamp with Fastener
FDA Device · Class II · 2018-06-06 · Arrow International - HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usag…
FDA Device · Class II · 2018-06-06 · Ethicon Endo Surgery - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
FDA Device · Class II · 2018-06-06 · Arrow International - Echogenic Needle
FDA Device · Class II · 2018-06-06 · Arrow International - Maximal Barrier Drape
FDA Device · Class II · 2018-06-06 · Arrow International - Heartware Medtronic HVAD System for cardiac use
FDA Device · Class I · 2018-06-06 · Heartware - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal…
FDA Device · Class II · 2018-06-06 · Arrow International - Peel Away Sheath over Dilator
FDA Device · Class II · 2018-06-06 · Arrow International - Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-06-06 · Arrow International - MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used saf…
FDA Device · Class II · 2018-06-06 · Medline Industries - CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-…
FDA Device · Class I · 2018-06-06 · Maquet Datascope Cardiac Assist Division - Clear Fenestrated Drape with Adhesive
FDA Device · Class II · 2018-06-06 · Arrow International - First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revisi…
FDA Device · Class II · 2018-05-30 · Smith And Nephew - Philips HeartStart (HS1) Onsite/Home AED
FDA Device · Class II · 2018-05-30 · Philips Electronics North America - Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component o…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Ca…
FDA Device · Class II · 2018-05-30 · Beckman Coulter - ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile
FDA Device · Class II · 2018-05-30 · Implant Direct Sybron Manufacturing - smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis
FDA Device · Class II · 2018-05-30 · Smith And Nephew - First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revi…
FDA Device · Class II · 2018-05-30 · Smith And Nephew - Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the o…
FDA Device · Class II · 2018-05-30 · Livanova Usa - ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile
FDA Device · Class II · 2018-05-30 · Implant Direct Sybron Manufacturing - Philips HeartStart FRx AED
FDA Device · Class II · 2018-05-30 · Philips Electronics North America - Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation
FDA Device · Class II · 2018-05-30 · Synthes Usa Products - smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated fo…
FDA Device · Class II · 2018-05-30 · Smith And Nephew - Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device i…
FDA Device · Class II · 2018-05-30 · Spinal Elements - Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and…
FDA Device · Class II · 2018-05-30 · Siemens Medical Solutions Usa - Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (C…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(…
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposabl…
FDA Device · Class II · 2018-05-30 · Baxter Healthcare - smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revi…
FDA Device · Class II · 2018-05-30 · Smith And Nephew - smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revis…
FDA Device · Class II · 2018-05-30 · Smith And Nephew - Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the o…
FDA Device · Class II · 2018-05-30 · Livanova Usa - Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz
FDA Device · Class II · 2018-05-30 · Livanova Usa - First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device
FDA Device · Class II · 2018-05-30 · Edwards Lifesciences - First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
FDA Device · Class II · 2018-05-30 · Madison Polymeric Engineering - ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient
FDA Device · Class II · 2018-05-30 · Getinge Us Sales - Nipro Blood Tubing set with Priming Set and Transducer Protectors
FDA Device · Class II · 2018-05-23 · Nipro Medical - (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA uni…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GI…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use On…
FDA Device · Class II · 2018-05-23 · Tosoh Bioscience - 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
FDA Device · Class II · 2018-05-23 · Ethicon Endo Surgery - BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of ti…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product Usage: The Endo GIA universal and Endo GIA unive…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
FDA Device · Class II · 2018-05-23 · Siemens Medical Solutions Usa - Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) Product Usage: The Endo GIA…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPEN…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Device · Class II · 2018-05-23 · Micro Tech Nanjing - BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo GIA universal and Endo GIA uni…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item n…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, trip…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tung…
FDA Device · Class II · 2018-05-23 · Coltene Whaledent - BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnost…
FDA Device · Class II · 2018-05-23 · Visaris Doo - BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access i…
FDA Device · Class II · 2018-05-23 · Bard Peripheral Vascular - Kelyniam Custom Skull Implant (CSI), Model no
FDA Device · Class II · 2018-05-23 · Kelyniam Global - 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
FDA Device · Class II · 2018-05-23 · Ethicon Endo Surgery - Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA un…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international…
FDA Device · Class II · 2018-05-23 · Invivo - Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term he…
FDA Device · Class I · 2018-05-23 · Abbott - SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 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 - Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/…
FDA Device · Class II · 2018-05-23 · Southmedic - Infinity Acute Care System (lACS) Monitoring Solution
FDA Device · Class II · 2018-05-23 · Draegar Medical Systems - (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX10…
FDA Device · Class II · 2018-05-23 · Covidien Medtronic - Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibratio…
FDA Device · Class II · 2018-05-23 · Tosoh Bioscience
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)