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.
- 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358
FDA Device · Class II · 2014-01-15 · Icu Medical - Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Devic…
FDA Device · Class II · 2014-01-15 · Alere San Diego - 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, P…
FDA Device · Class II · 2014-01-15 · Icu Medical - 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleles…
FDA Device · Class II · 2014-01-15 · Icu Medical - 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item…
FDA Device · Class II · 2014-01-15 · Icu Medical - 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, P…
FDA Device · Class II · 2014-01-15 · Icu Medical - 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a si…
FDA Device · Class II · 2014-01-15 · Icu Medical - The Propaq LT Series monitors
FDA Device · Class II · 2014-01-15 · Welch Allyn Protocol - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Need…
FDA Device · Class II · 2014-01-15 · Icu Medical - 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleles…
FDA Device · Class II · 2014-01-15 · Icu Medical - Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed…
FDA Device · Class II · 2014-01-15 · Smiths Medical Asd - Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mech…
FDA Device · Class I · 2014-01-15 · Covidien - 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Co…
FDA Device · Class II · 2014-01-15 · Icu Medical - 7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No.…
FDA Device · Class II · 2014-01-15 · Icu Medical - 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needlel…
FDA Device · Class II · 2014-01-15 · Icu Medical - REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST…
FDA Device · Class II · 2014-01-15 · Materialise Usa - 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a s…
FDA Device · Class II · 2014-01-15 · Icu Medical - PedFuse Bone Probe
FDA Device · Class II · 2014-01-15 · Spinefrontier - ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc
FDA Device · Class II · 2014-01-15 · The Anspach Effort - ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc
FDA Device · Class II · 2014-01-15 · The Anspach Effort - Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and sha…
FDA Device · Class II · 2014-01-15 · Aesculap - 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The I…
FDA Device · Class II · 2014-01-15 · Icu Medical - 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Conn…
FDA Device · Class II · 2014-01-15 · Icu Medical - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Me…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - 7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connec…
FDA Device · Class II · 2014-01-15 · Icu Medical - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx…
FDA Device · Class II · 2014-01-15 · Stryker Instruments Div - Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed…
FDA Device · Class II · 2014-01-15 · Smiths Medical Asd - Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in
FDA Device · Class II · 2014-01-15 · Smiths Medical Asd - 30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No…
FDA Device · Class II · 2014-01-15 · Icu Medical - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No.…
FDA Device · Class II · 2014-01-15 · Icu Medical - EOS System X- ray beam Digital radiography system used in general radiographic examinations
FDA Device · Class II · 2014-01-15 · Eos Imaging - 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needle…
FDA Device · Class II · 2014-01-15 · Icu Medical - 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812
FDA Device · Class II · 2014-01-15 · Icu Medical - 8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Co…
FDA Device · Class II · 2014-01-15 · Icu Medical - 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item…
FDA Device · Class II · 2014-01-15 · Icu Medical - 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No.…
FDA Device · Class II · 2014-01-15 · Icu Medical - Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
FDA Device · Class II · 2014-01-15 · Arthrocare Medical - 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConne…
FDA Device · Class II · 2014-01-15 · Icu Medical - The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including…
FDA Device · Class II · 2014-01-15 · Midmark - 6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp,…
FDA Device · Class II · 2014-01-15 · Icu Medical - On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Device · Class II · 2014-01-15 · On Site Gas Systems - ***REF IMRI-MOTOR***iMRI Handpiece
FDA Device · Class II · 2014-01-15 · The Anspach Effort - 7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic devic…
FDA Device · Class II · 2014-01-15 · Icu Medical - 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector…
FDA Device · Class II · 2014-01-15 · Icu Medical - 8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A…
FDA Device · Class II · 2014-01-15 · Icu Medical - 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, steril…
FDA Device · Class II · 2014-01-15 · Icu Medical - 87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, P…
FDA Device · Class II · 2014-01-15 · Icu Medical - Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The IC…
FDA Device · Class II · 2014-01-15 · Icu Medical - Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The…
FDA Device · Class II · 2014-01-15 · Carestream Health - 6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needlele…
FDA Device · Class II · 2014-01-15 · Icu Medical - 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lo…
FDA Device · Class II · 2014-01-15 · Icu Medical - 10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The I…
FDA Device · Class II · 2014-01-15 · Icu Medical - Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome
FDA Device · Class II · 2014-01-15 · The Anspach Effort - 13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless C…
FDA Device · Class II · 2014-01-15 · Icu Medical - 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243
FDA Device · Class II · 2014-01-15 · Icu Medical - 17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Co…
FDA Device · Class II · 2014-01-15 · Icu Medical - Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz…
FDA Device · Class II · 2014-01-15 · Optimedica - 184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector,…
FDA Device · Class II · 2014-01-15 · Icu Medical - Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch Syst…
FDA Device · Class II · 2014-01-15 · Trans American Medical - Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro¿ Fixed…
FDA Device · Class II · 2014-01-15 · Smiths Medical Asd - Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536…
FDA Device · Class II · 2014-01-15 · Integra Lifesciences - Nova StatStrip/StatSensor Hospital Blood Glucose Meter
FDA Device · Class II · 2014-01-15 · Nova Biomedical - Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control)
FDA Device · Class II · 2014-01-15 · The Anspach Effort - 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Ne…
FDA Device · Class II · 2014-01-15 · Icu Medical - 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿,…
FDA Device · Class II · 2014-01-15 · Icu Medical - HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems
FDA Device · Class II · 2014-01-15 · Siemens Healthcare Diagnostics - C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices th…
FDA Device · Class II · 2014-01-15 · Rti Surgical - ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc
FDA Device · Class II · 2014-01-15 · The Anspach Effort - NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended…
FDA Device · Class II · 2014-01-15 · Icu Medical - 10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The…
FDA Device · Class II · 2014-01-15 · Icu Medical - 10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotati…
FDA Device · Class II · 2014-01-15 · Icu Medical - 5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector…
FDA Device · Class II · 2014-01-15 · Icu Medical - HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems
FDA Device · Class II · 2014-01-15 · Siemens Healthcare Diagnostics - 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 27912…
FDA Device · Class II · 2014-01-15 · Icu Medical - 11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleles…
FDA Device · Class II · 2014-01-15 · Icu Medical - Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536…
FDA Device · Class II · 2014-01-15 · Integra Lifesciences - 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless…
FDA Device · Class II · 2014-01-15 · Icu Medical - NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, s…
FDA Device · Class II · 2014-01-15 · Icu Medical - Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, M…
FDA Device · Class II · 2014-01-15 · The Anspach Effort - Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (C…
FDA Device · Class II · 2014-01-15 · Smiths Medical Asd - 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244
FDA Device · Class II · 2014-01-15 · Icu Medical - Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated fo…
FDA Device · Class II · 2014-01-15 · Fresenius Medical Care Holdings - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Me…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity
FDA Device · Class II · 2014-01-15 · Invacare - AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negati…
FDA Device · Class III · 2014-01-08 · Advandx - Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and w…
FDA Device · Class II · 2014-01-08 · Synthes Usa Hq - FEM COND BUTTRESS PLT, RT
FDA Device · Class II · 2014-01-08 · Zimmer - IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its fo…
FDA Device · Class II · 2014-01-08 · Baxter Healthcare - Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed…
FDA Device · Class II · 2014-01-08 · Asante Solutions - Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation L…
FDA Device · Class II · 2014-01-08 · Terumo Cardiovascular Systems - Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4)
FDA Device · Class II · 2014-01-08 · Asante Solutions - RTC 25-C Inline Aerosol Tee Adapter
FDA Device · Class II · 2014-01-08 · Instrumentation Industries - TIBIO FEM/FEM NAIL
FDA Device · Class II · 2014-01-08 · Zimmer - SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilan…
FDA Device · Class II · 2014-01-08 · Steris - Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4)
FDA Device · Class II · 2014-01-08 · Asante Solutions - S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals
FDA Device · Class II · 2014-01-08 · Stryker Medical Division
Other years
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