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.
- Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I)…
FDA Device · Class I · 2014-09-10 · Customed - LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH…
FDA Device · Class I · 2014-09-10 · Customed - GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF…
FDA Device · Class I · 2014-09-10 · Customed - Natural-Knee System Patella Bushings
FDA Device · Class II · 2014-09-10 · Zimmer - Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE…
FDA Device · Class I · 2014-09-10 · Customed - C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS…
FDA Device · Class I · 2014-09-10 · Customed - HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE…
FDA Device · Class I · 2014-09-10 · Customed - H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN B…
FDA Device · Class II · 2014-09-03 · Zimmer - H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2014-09-03 · Zimmer - 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400
FDA Device · Class II · 2014-09-03 · Curbell Medical - The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to…
FDA Device · Class II · 2014-09-03 · Thermedx - CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes
FDA Device · Class II · 2014-09-03 · Civco Medical Instruments - BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, inte…
FDA Device · Class II · 2014-09-03 · Becton Dickinson And - Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST F…
FDA Device · Class II · 2014-09-03 · Zimmer - Cordis EMPIRA NC RX PTCA Dilatation Catheter
FDA Device · Class II · 2014-09-03 · Cordis - Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA…
FDA Device · Class II · 2014-09-03 · Zimmer - Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM D…
FDA Device · Class II · 2014-09-03 · Zimmer - Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75…
FDA Device · Class II · 2014-09-03 · Zimmer - H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left
FDA Device · Class II · 2014-09-03 · Zimmer - Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522…
FDA Device · Class II · 2014-09-03 · Medtronic Minimed - CloverSnare 4-Loop Vascular Retrieval Snare
FDA Device · Class I · 2014-09-03 · Cook - Cordis EMPIRA RX PTCA Dilatation Catheter
FDA Device · Class II · 2014-09-03 · Cordis - H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
FDA Device · Class II · 2014-09-03 · Zimmer - Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test)
FDA Device · Class III · 2014-09-03 · Nanosphere - H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
FDA Device · Class I · 2014-09-03 · Smiths Medical Asd - Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids
FDA Device · Class II · 2014-09-03 · Siemens Healthcare Diagnostics - Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT…
FDA Device · Class II · 2014-09-03 · Zimmer - TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTA…
FDA Device · Class II · 2014-08-27 · Smith And Nephew - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sourc…
FDA Device · Class II · 2014-08-27 · Intelerad Medical Systems - 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface f…
FDA Device · Class II · 2014-08-27 · Ortho Development - Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP…
FDA Device · Class II · 2014-08-27 · Zimmer - Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other…
FDA Device · Class II · 2014-08-27 · Icu Medical - PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to orga…
FDA Device · Class II · 2014-08-27 · Zimmer - Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP…
FDA Device · Class II · 2014-08-27 · Zimmer - TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1)
FDA Device · Class II · 2014-08-27 · Tomotherapy - CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components
FDA Device · Class II · 2014-08-27 · Icu Medical - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +…
FDA Device · Class II · 2014-08-27 · Zimmer - Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system
FDA Device · Class II · 2014-08-27 · Ansar Group - Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERIL…
FDA Device · Class II · 2014-08-27 · Angiodynamics - Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - Apex Arc Hip Stem, Size 2, HA Coated
FDA Device · Class II · 2014-08-27 · Omnilife Science - Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only
FDA Device · Class II · 2014-08-27 · Medtronic Neuromodulation - 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System
FDA Device · Class II · 2014-08-27 · Philips Medical Systems - Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD T…
FDA Device · Class II · 2014-08-27 · Zimmer - Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERIL…
FDA Device · Class II · 2014-08-27 · Angiodynamics - PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation…
FDA Device · Class II · 2014-08-27 · Ortho Development - PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to orga…
FDA Device · Class II · 2014-08-27 · Zimmer - GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, a…
FDA Device · Class II · 2014-08-27 · Ge Healthcare - DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Device · Class I · 2014-08-27 · Synthes - Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage
FDA Device · Class II · 2014-08-27 · Philips Healthcare Informatics - Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
FDA Device · Class II · 2014-08-27 · Zimmer - Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays
FDA Device · Class II · 2014-08-27 · Siemens Healthcare Diagnostics - Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring B…
FDA Device · Class II · 2014-08-27 · Gyrus Medical - Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to ser…
FDA Device · Class II · 2014-08-27 · Ortho Development - 4.5 mm Malleolar Screw Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monit…
FDA Device · Class II · 2014-08-27 · Invivo - 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463
FDA Device · Class II · 2014-08-27 · Biolase Technology - Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST…
FDA Device · Class II · 2014-08-27 · Biomet - Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and othe…
FDA Device · Class II · 2014-08-27 · Icu Medical - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate w…
FDA Device · Class II · 2014-08-27 · Ortho Development - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERIL…
FDA Device · Class II · 2014-08-27 · Angiodynamics - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
FDA Device · Class II · 2014-08-27 · Synthes - Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing sur…
FDA Device · Class II · 2014-08-27 · Ortho Development - All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online informat…
FDA Device · Class II · 2014-08-27 · Hyperion Medical - 4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2…
FDA Device · Class II · 2014-08-27 · Tomotherapy - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV…
FDA Device · Class II · 2014-08-27 · Zimmer - PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
FDA Device · Class II · 2014-08-27 · Pentax Medical - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
FDA Device · Class II · 2014-08-27 · Zimmer - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002
FDA Device · Class II · 2014-08-27 · Amo Puerto Rico Manufacturing - Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body
FDA Device · Class I · 2014-08-27 · Childrens Medical Ventures - Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
FDA Device · Class II · 2014-08-27 · Vascutek - Prismaflex M60 set
FDA Device · Class II · 2014-08-20 · Gambro Renal Products - Codman Certas - In Line Valve with Catheter and Accessories
FDA Device · Class II · 2014-08-20 · Codman And Shurtleff - EndoWrist Stapler System User Manual Addendum and Wall Chart
FDA Device · Class II · 2014-08-20 · Intuitive Surgical
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)