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.
- Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish pe…
FDA Device · Class II · 2018-03-28 · Boston Scientific - SUTURE REMOVAL TRAY, SET or KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation
FDA Device · Class I · 2018-03-28 · Monteris Medical - U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplas…
FDA Device · Class II · 2018-03-28 · United Orthopedic - J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
FDA Device · Class II · 2018-03-28 · Bovie Medical - INCISION & DRAINAGE TRAY or KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - BD Vacutainer¿ EDTA Pink Top Tube
FDA Device · Class I · 2018-03-28 · Becton Dickinson And - J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
FDA Device · Class II · 2018-03-28 · Bovie Medical - J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
FDA Device · Class II · 2018-03-28 · Bovie Medical - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety F…
FDA Device · Class II · 2018-03-28 · Arrow International - BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011)
FDA Device · Class I · 2018-03-28 · Becton Dickinson And - Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids…
FDA Device · Class II · 2018-03-28 · Smiths Medical Asd - Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are de…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a h…
FDA Device · Class II · 2018-03-28 · Iridex - SwishPlus Implant Intended for use in support for fixed bridgework
FDA Device · Class II · 2018-03-28 · Implant Direct Sybron Manufacturing - Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to est…
FDA Device · Class II · 2018-03-28 · Boston Scientific - Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids…
FDA Device · Class II · 2018-03-28 · Smiths Medical Asd - Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to est…
FDA Device · Class II · 2018-03-28 · Boston Scientific - TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female he…
FDA Device · Class II · 2018-03-28 · Medical Components - MyLab Ultrasound System
FDA Device · Class II · 2018-03-28 · Esaote S P A - DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easil…
FDA Device · Class II · 2018-03-28 · Ethicon - CATHETER SECUREMENT SYSTEM
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is inten…
FDA Device · Class II · 2018-03-28 · Boston Scientific - PEDIATRIC IV & IV START KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - GENERAL PURPOSE INSTRUMENT TRAY
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female…
FDA Device · Class II · 2018-03-28 · Medical Components - Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14…
FDA Device · Class II · 2018-03-28 · Merit Medical Systems - TUBING CHANGE KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - NEONATAL IV ACCESS SET
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - BD Vacutainer¿ Lithium Heparin Green Top Tube
FDA Device · Class I · 2018-03-28 · Becton Dickinson And - REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connect…
FDA Device · Class II · 2018-03-28 · Medical Components - AutoMate 2550 "High Speed" Catalog Number ODL25255
FDA Device · Class II · 2018-03-28 · Beckman Coulter - EXCISION TRAY
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female…
FDA Device · Class II · 2018-03-28 · Medical Components - SwishTapered Implant Intended for use in support for fixed bridgework
FDA Device · Class II · 2018-03-28 · Implant Direct Sybron Manufacturing - 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in…
FDA Device · Class II · 2018-03-28 · Medical Components - 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in…
FDA Device · Class II · 2018-03-28 · Medical Components - Pressure Injectable Multi- Lumen CVC Kit
FDA Device · Class II · 2018-03-28 · Arrow International - MINOR DRESSING CHANGE TRAY
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - LATEX FREE IV START SET
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is inten…
FDA Device · Class II · 2018-03-28 · Boston Scientific - ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to cent…
FDA Device · Class II · 2018-03-28 · Arrow International - Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with…
FDA Device · Class II · 2018-03-28 · Medica - J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
FDA Device · Class II · 2018-03-28 · Bovie Medical - ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of phy…
FDA Device · Class II · 2018-03-28 · Vascular Insights - NEONATAL IV START KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - SKIN STAPLE REMOVER
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Featur…
FDA Device · Class II · 2018-03-28 · Arrow International - Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Ba…
FDA Device · Class II · 2018-03-28 · Arrow International - WOUND CLOSURE TRAY - FACIAL
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated i…
FDA Device · Class II · 2018-03-28 · United Orthopedic - BD Vacutainer¿ EDTA Tan Top Tube
FDA Device · Class I · 2018-03-28 · Becton Dickinson And - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Feature…
FDA Device · Class II · 2018-03-28 · Arrow International - ST. CHRISTOPHER'S SECUREMENT SET
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - AutoMate 1200 Catalog Number ODL25120
FDA Device · Class II · 2018-03-28 · Beckman Coulter - MyLab Ultrasound System
FDA Device · Class II · 2018-03-28 · Esaote S P A - Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventiona…
FDA Device · Class II · 2018-03-28 · Siemens Medical Solutions Usa - Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use…
FDA Device · Class II · 2018-03-28 · Arrow International - 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing d…
FDA Device · Class II · 2018-03-28 · Medical Components - Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
FDA Device · Class II · 2018-03-28 · Merit Medical Systems - GENICON EZEE Retrieval, sterile, Rx only
FDA Device · Class II · 2018-03-28 · Genicon - IV START KIT
FDA Device · Class II · 2018-03-28 · Centurion Medical Products - FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM P…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Alden HP59 Sphere Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - Accolade and Restoration hip product
FDA Device · Class II · 2018-03-21 · Howmedica Osteonics - Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA Device · Class III · 2018-03-21 · Randox Laboratories - Alden HP49 Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints d…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arr…
FDA Device · Class II · 2018-03-21 · Arrow International - Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) c…
FDA Device · Class II · 2018-03-21 · Arrow International - Newton Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - NovaKone Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - 36MM COCR MODULAR HD -6MM
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - SYSTEM 26
FDA Device · Class II · 2018-03-21 · Ortho Solutions - Central Venous Catheter Tray
FDA Device · Class II · 2018-03-21 · Cook - ReWalk Personal 6.0. Catalog number: 50-20-0004
FDA Device · Class II · 2018-03-21 · Argo Medical Technologies - CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
FDA Device · Class II · 2018-03-21 · 3m Health Care Business - TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel durin…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF O…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX O…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natur…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841
FDA Device · Class II · 2018-03-21 · Becton Dickinson And - 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medic…
FDA Device · Class II · 2018-03-21 · Brainlab Ag - Double Flexible Tipped Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Trabecular Metal¿ Primary Hip Prosthesis
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 89…
FDA Device · Class II · 2018-03-21 · Zoll Medical - LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain an…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with local…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications - VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet
Other years
2026 (2,088) · 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)