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.
- 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic sur…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surge…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedi…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - Surgical punch
FDA Device · Class II · 2018-03-07 · Alto Development - Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only
FDA Device · Class II · 2018-03-07 · Cosmedent - NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-…
FDA Device · Class II · 2018-03-07 · Nxstage Medical - Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Syst…
FDA Device · Class II · 2018-03-07 · Stryker Communications - Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Device · Class II · 2018-03-07 · Cook - OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Truth Renew Plus
FDA Device · Class II · 2018-03-07 · Accord Media - iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
FDA Device · Class II · 2018-03-07 · Aesculap Implant Systems - OTTO BOCK Kenevo knee joints Model 3C60=ST
FDA Device · Class II · 2018-03-07 · Otto Bock Healthcare Product - Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
FDA Device · Class II · 2018-03-07 · Avid Medical - Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Car…
FDA Device · Class II · 2018-03-07 · Philips Electronics North America - ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
FDA Device · Class II · 2018-03-07 · Tosoh Bioscience - AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
FDA Device · Class II · 2018-03-07 · Avid Medical - AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
FDA Device · Class II · 2018-03-07 · Avid Medical - Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as…
FDA Device · Class II · 2018-03-07 · Keystone Dental - 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - Zimmer Segmental System, ZSS Distal Femur
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, pac…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
FDA Device · Class II · 2018-03-07 · Avid Medical - AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
FDA Device · Class II · 2018-03-07 · Avid Medical - Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
FDA Device · Class II · 2018-03-07 · Stryker Communications - Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Ultra Renew
FDA Device · Class II · 2018-03-07 · Accord Media - STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Exte…
FDA Device · Class II · 2018-03-07 · Conmed - 3M Surgical Clipper Professional 9681
FDA Device · Class II · 2018-03-07 · 3m Health Care Business - OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage
FDA Device · Class II · 2018-03-07 · Philips Electronics North America - AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir
FDA Device · Class II · 2018-03-07 · Circulatory Technology - Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision…
FDA Device · Class II · 2018-03-07 · Alcon Research - Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric…
FDA Device · Class II · 2018-03-07 · Cook - AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site wi…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (P…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - Vis-U-All High Temperature Tubing 6"x100'. One roll per box
FDA Device · Class II · 2018-03-07 · Steris - Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to fac…
FDA Device · Class III · 2018-03-07 · Perkinelmer Life Sciences - Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2018-03-07 · Integra Lifesciences - AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
FDA Device · Class II · 2018-03-07 · Avid Medical - Syngo.via systems with SW VB20A
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentul…
FDA Device · Class II · 2018-03-07 · Keystone Dental - OTTO BOCK Kenevo knee joints Model 3C60
FDA Device · Class II · 2018-03-07 · Otto Bock Healthcare Product - AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
FDA Device · Class II · 2018-03-07 · Avid Medical - ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or…
FDA Device · Class II · 2018-03-07 · Atrium Medical - Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - 979195 Loaner Kit for femoral intramedullary nail
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the c…
FDA Device · Class III · 2018-03-07 · Coopervision - MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with t…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using t…
FDA Device · Class II · 2018-03-07 · Siemens Healthcare Diagnostics - Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Device · Class II · 2018-03-07 · Cook - ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and n…
FDA Device · Class II · 2018-03-07 · Hitachi Medical Systems America - AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications f…
FDA Device · Class II · 2018-03-07 · Mobius Imaging - Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
FDA Device · Class II · 2018-03-07 · Avid Medical - AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
FDA Device · Class II · 2018-03-07 · Avid Medical - Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of…
FDA Device · Class II · 2018-03-07 · Trumpf Medical Systems - STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2…
FDA Device · Class II · 2018-03-07 · Conmed - Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert…
FDA Device · Class II · 2018-03-07 · Howmedica Osteonics - Integrity R1.2
FDA Device · Class II · 2018-03-07 · Elekta - AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - The 2nd Assist Knee Positioner
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infa…
FDA Device · Class II · 2018-03-07 · Zoll Medical - CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Better-Bladder cardiopulmonary bypass blood reservoir
FDA Device · Class II · 2018-03-07 · Circulatory Technology - DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder…
FDA Device · Class II · 2018-03-07 · Depuy Orthopaedics - Vis-U-All High Temperature Tubing 9"x100'. One roll per box
FDA Device · Class II · 2018-03-07 · Steris - Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Ultra Renew Plus
FDA Device · Class II · 2018-03-07 · Accord Media - Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sec…
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
FDA Device · Class II · 2018-03-07 · Avid Medical - Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Vis-U-All High Temperature Tubing 4"x100'. One roll per box
FDA Device · Class II · 2018-03-07 · Steris
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)