FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem comp…
FDA Device · Class II · 2014-07-16 · Zimmer - Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to fa…
FDA Device · Class II · 2014-07-16 · Hospira - STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
FDA Device · Class II · 2014-07-16 · B Braun Medical - GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476
FDA Device · Class II · 2014-07-16 · Philips Medical Systems Cleveland - VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous ev…
FDA Device · Class II · 2014-07-16 · Vascular Technology - Intuitive Surgical Inc
FDA Device · Class II · 2014-07-16 · Intuitive Surgical - Amerigel Wound Dressing 1 oz. tube
FDA Device · Class II · 2014-07-16 · Kova Laboratories - 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation…
FDA Device · Class II · 2014-07-16 · Vascular Technology - The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general s…
FDA Device · Class II · 2014-07-16 · Steris - Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box s…
FDA Device · Class II · 2014-07-16 · Aesculap - 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluatio…
FDA Device · Class II · 2014-07-16 · Vascular Technology - Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLO…
FDA Device · Class II · 2014-07-16 · Zimmer Manufacturing B V - Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family
FDA Device · Class II · 2014-07-16 · Invacare - Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
FDA Device · Class II · 2014-07-16 · Terumo Cardiovascular Systems - Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended f…
FDA Device · Class III · 2014-07-16 · Steris - Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluat…
FDA Device · Class II · 2014-07-16 · Vascular Technology - Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit
FDA Device · Class II · 2014-07-16 · Karl Storz Endoscopy - Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.2…
FDA Device · Class II · 2014-07-16 · Zimmer - Devon Supine, Lithotomy and Trendelenburg Positioning Kit
FDA Device · Class II · 2014-07-16 · Covidien - HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer
FDA Device · Class II · 2014-07-16 · Cenorin - PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter
FDA Device · Class II · 2014-07-16 · Pall - Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures
FDA Device · Class II · 2014-07-16 · Rgi Medical Manufacturing - Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
FDA Device · Class II · 2014-07-16 · Carefusion 303 - Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem com…
FDA Device · Class II · 2014-07-16 · Zimmer - Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
FDA Device · Class II · 2014-07-16 · Terumo Cardiovascular Systems - Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS…
FDA Device · Class II · 2014-07-16 · Codan Us - Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial
FDA Device · Class II · 2014-07-09 · Blue Belt Technologies Mn - Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - CNS-6200 Series Central Nurse Station and accessories
FDA Device · Class II · 2014-07-09 · Nihon Kohden America - Integra¿ LED Battery Charger, Single Bay
FDA Device · Class II · 2014-07-09 · Integra Lifesciences - GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use…
FDA Device · Class II · 2014-07-09 · Ge Healthcare - Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct
FDA Device · Class II · 2014-07-09 · Focus Diagnostics - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery - DeVilbiss Model DV5x Series CPAP units
FDA Device · Class III · 2014-07-09 · Devilbiss Healthcare - Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden,…
FDA Device · Class II · 2014-07-09 · Medical Action Industries - Stirling Ultracold Portable Shuttle, ULT-25
FDA Device · Class II · 2014-07-09 · Global Cooling - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - Vision Troubleshooting Guide for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Synthes B37 Replacement Screws
FDA Device · Class II · 2014-07-09 · Synthes - Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory
FDA Device · Class II · 2014-07-09 · Origio - EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR
FDA Device · Class II · 2014-07-09 · Baxter Healthcare - Non-Mydriatic Auto Fundus Camera
FDA Device · Class II · 2014-07-09 · Nidek - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of…
FDA Device · Class II · 2014-07-09 · Stryker Howmedica Osteonics - Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
FDA Device · Class II · 2014-07-09 · Microline Surgical - Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - Insert for IRK for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Cautery QRG for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - IRK QRG for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for…
FDA Device · Class II · 2014-07-09 · Siemens Medical Solutions Usa - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery - ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B
FDA Device · Class II · 2014-07-09 · Siemens Medical Solutions Usa - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Connection QRG for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Vessel Sealer QRG for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics
FDA Device · Class II · 2014-07-09 · Bd Biosciences Systems And Reagents - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen syst…
FDA Device · Class II · 2014-07-09 · Zimmer - Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis
FDA Device · Class II · 2014-07-09 · Baxter Healthcare - Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14…
FDA Device · Class II · 2014-07-09 · Alcon Research - GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all gener…
FDA Device · Class II · 2014-07-09 · Ge Healthcare - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery - MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge
FDA Device · Class II · 2014-07-09 · Siemens Healthcare Diagnostics - Vessel Sealer Addendum for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573
FDA Device · Class II · 2014-07-09 · Siemens Healthcare Diagnostics - System Manual for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM300…
FDA Device · Class I · 2014-07-09 · Ventlab - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery - The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid
FDA Device · Class II · 2014-07-09 · Claymount Assembli - Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
FDA Device · Class II · 2014-07-09 · Microline Surgical - ADVIA Centaur¿ Systems TnI-Ultra assay
FDA Device · Class II · 2014-07-09 · Siemens Healthcare Diagnostics - Stapler Addendum for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - Natural Rubber Latex QRG for the da Vinci Standard Surgical System
FDA Device · Class II · 2014-07-09 · Intuitive Surgical - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus
FDA Device · Class II · 2014-07-09 · Atrium Medical - The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid
FDA Device · Class II · 2014-07-09 · Claymount Assembli - ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581)…
FDA Device · Class II · 2014-07-09 · Siemens Healthcare Diagnostics - Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540
FDA Device · Class I · 2014-07-09 · Vascular Solutions - Anspach Pneumatic and Electric Motor Systems
FDA Device · Class II · 2014-07-09 · The Anspach Effort
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)