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.
- Liquid Cardiac Control CQ5053
FDA Device · Class II · 2018-03-21 · Randox Laboratories - ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) ce…
FDA Device · Class II · 2018-03-21 · Arrow International - Left Atrial Catheter Set
FDA Device · Class II · 2018-03-21 · Cook - CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZ…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic su…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are intend…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE, Rx Only Product Usage: The LaserEdge Knives are int…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only Product Usage: The LaserEdge K…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures
FDA Device · Class II · 2018-03-14 · Boston Scientific - LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, STERILE, Rx Only Product Usage: The LaserEdge Knives are inte…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Brilliance Big Bore Oncology CTwith 4.2.0 software version
FDA Device · Class II · 2018-03-14 · Philips Medical Systems Cleveland - LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only Product Usage: The LaserEdge Knives a…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - A-Series A3/A5 Anesthesia Delivery System
FDA Device · Class II · 2018-03-14 · Mindray Ds Usa - IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Device · Class II · 2018-03-14 · Philips Medical Systems Cleveland - INFX-8000V Fluoroscopic X-Ray Systems
FDA Device · Class II · 2018-03-14 · Toshiba American Medical Systems - Proteus 235, graphite block 8
FDA Device · Class II · 2018-03-14 · Ion Beam Applications - INFX-8000C Fluoroscopic X-Ray Systems
FDA Device · Class II · 2018-03-14 · Toshiba American Medical Systems - Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine
FDA Device · Class II · 2018-03-14 · Depuy Orthopaedics - ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system
FDA Device · Class II · 2018-03-14 · Abbott Laboratories - STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile
FDA Device · Class II · 2018-03-14 · Stryker - LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, STERILE, Rx Only Product Usage: The LaserEdge Knives are inte…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE, Rx Only Product Usage: The LaserEdge Knives are int…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - A-Series A7 Anesthesia Delivery System
FDA Device · Class II · 2018-03-14 · Mindray Ds Usa - 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic su…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only Product Usage: The LaserEdg…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile
FDA Device · Class III · 2018-03-14 · Degania Silicone - LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only Product Usage: The LaserEdge Kniv…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions
FDA Device · Class II · 2018-03-14 · Z Medica - LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, STERILE, Rx Only Product Usage: The LaserEdge Knives are in…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or mini…
FDA Device · Class II · 2018-03-14 · Covidien - BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to…
FDA Device · Class II · 2018-03-14 · Medtronic Perfusion Systems - LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives ar…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: The La…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The LaserEdge Kn…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE, Rx Only Product Usage: The LaserEdge…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, STERILE, Rx Only Product Usage: The LaserEdge Knives a…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
FDA Device · Class II · 2018-03-14 · Instrumentation Laboratory - 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during o…
FDA Device · Class II · 2018-03-14 · Synthes Usa Products - LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, STERILE, Rx Only Product Usage: The LaserEdge K…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - O-arm 1000 mobile image-intensified fluoroscopic x-ray system
FDA Device · Class II · 2018-03-14 · Medtronic Navigation Littleton - LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives are in…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Signature Ceramic Femoral Head
FDA Device · Class II · 2018-03-14 · Signature Orthopedics - LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives ar…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - StrykeFlow 2 System, labeled sterile
FDA Device · Class II · 2018-03-14 · Stryker - Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reproces…
FDA Device · Class II · 2018-03-14 · Stryker Sustainability Solutions - Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries
FDA Device · Class II · 2018-03-14 · Zimmer Biomet - INFX-8000F Fluoroscopic X-Ray Systems
FDA Device · Class II · 2018-03-14 · Toshiba American Medical Systems - ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system
FDA Device · Class II · 2018-03-14 · Abbott Laboratories - Brilliance Big Bore Radiology CT with 4.2.0 software version
FDA Device · Class II · 2018-03-14 · Philips Medical Systems Cleveland - LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only Product Usage: The LaserEdge K…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The LaserEdge Kn…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, STERILE, Rx Only Product Usage: The LaserEdge Knives are int…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intend…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, STERILE, Rx Only Product Usage: The LaserEdge Kn…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter
FDA Device · Class II · 2018-03-14 · Medtronic Neuromodulation - Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures
FDA Device · Class II · 2018-03-14 · Boston Scientific - LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, STERILE, Rx Only Product Usage: The LaserEdge Knives are…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries
FDA Device · Class II · 2018-03-14 · Zimmer Biomet - DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200
FDA Device · Class II · 2018-03-14 · Euro Diagnostica Ab - LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge Knive…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Kniv…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress…
FDA Device · Class II · 2018-03-14 · Cypress Medical Products - LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system
FDA Device · Class II · 2018-03-14 · Abbott Laboratories - i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
FDA Device · Class II · 2018-03-14 · Abbott Point - VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knive…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease
FDA Device · Class II · 2018-03-14 · Wiener Laboratories - The GC80 Digital X-ray Imaging System
FDA Device · Class II · 2018-03-14 · Neurologica - Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reproces…
FDA Device · Class II · 2018-03-14 · Stryker Sustainability Solutions - Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)…
FDA Device · Class II · 2018-03-14 · Ion Beam Applications - O-arm¿ O2 interventional fluoroscopic x-ray system
FDA Device · Class II · 2018-03-14 · Medtronic Navigation Littleton - cobas 6000 Modular Series system
FDA Device · Class II · 2018-03-14 · Roche Diagnostics - LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, STERILE, Rx Only Product Usage: The LaserEdge Kniv…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx Only Product Usage: The LaserEdge Knives are inten…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - INFX-8000H Fluoroscopic X-Ray Systems
FDA Device · Class II · 2018-03-14 · Toshiba American Medical Systems - ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile
FDA Device · Class II · 2018-03-14 · Stryker - VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - Concorde Lift Torque Limiting Handle
FDA Device · Class II · 2018-03-14 · Depuy Orthopaedics - STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile
FDA Device · Class II · 2018-03-14 · Stryker - cobas 8000 Modular Analyzer Series
FDA Device · Class II · 2018-03-14 · Roche Diagnostics - LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only Product Usage: The LaserEdge Kniv…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - Philips Network Firewall (Cisco ASA 5506), Model # 867098
FDA Device · Class II · 2018-03-14 · Philips Electronics North America - LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only Product Usage: The LaserEdge…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb - LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives are int…
FDA Device · Class II · 2018-03-14 · Bausch And Lomb Irb
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)