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.
- Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospi…
FDA Device · Class II · 2014-10-29 · Codman And Shurtleff - Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119
FDA Device · Class II · 2014-10-29 · Boston Scientific Crm - DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
FDA Device · Class II · 2014-10-29 · Deroyal Industries - Mortara Surveyor S12 and Surveyor S19 Patient Monitors
FDA Device · Class II · 2014-10-29 · Mortara Instrument - Philips IntelliVue Monitors with software revisions J.21.03, J.21.19
FDA Device · Class II · 2014-10-29 · Philips Medical Systems - Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers
FDA Device · Class II · 2014-10-29 · Siemens Medical Solutions Usa - The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-pr…
FDA Device · Class II · 2014-10-29 · Aerogen - Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648)
FDA Device · Class II · 2014-10-29 · Signal Medical - Esprit V1000 and V200 Ventilators, Model No. V1000 and V200
FDA Device · Class I · 2014-10-29 · Respironics California - Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent
FDA Device · Class II · 2014-10-29 · Siemens Healthcare Diagnostics - The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-pr…
FDA Device · Class II · 2014-10-29 · Aerogen - Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM)…
FDA Device · Class II · 2014-10-29 · Deroyal Industries - Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp
FDA Device · Class II · 2014-10-29 · Signal Medical - Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospi…
FDA Device · Class II · 2014-10-29 · Codman And Shurtleff - Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal f…
FDA Device · Class II · 2014-10-29 · Codman And Shurtleff - DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
FDA Device · Class II · 2014-10-29 · Synthes - AC Powered adjustable bed frame
FDA Device · Class II · 2014-10-22 · Primus Medical - External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analy…
FDA Device · Class II · 2014-10-22 · Siemens Healthcare Diagnostics - Multi-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2014-10-22 · Arrow International - V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection
FDA Device · Class II · 2014-10-22 · Kci Usa - External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer
FDA Device · Class II · 2014-10-22 · Siemens Healthcare Diagnostics - eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System)
FDA Device · Class II · 2014-10-22 · Merge Healthcare - Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13
FDA Device · Class II · 2014-10-22 · Stryker Howmedica Osteonics - Philips Expression MR200 MRI Patient Monitoring System
FDA Device · Class II · 2014-10-22 · Invivo - ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qu…
FDA Device · Class II · 2014-10-22 · Ameditech - Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
FDA Device · Class I · 2014-10-22 · Covidien - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445
FDA Device · Class II · 2014-10-22 · Ortho Clinical Diagnostics - EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System
FDA Device · Class II · 2014-10-22 · Intuitive Surgical - Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
FDA Device · Class I · 2014-10-22 · Covidien - ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qua…
FDA Device · Class II · 2014-10-22 · Ameditech - Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe
FDA Device · Class II · 2014-10-22 · Arrow International - Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift
FDA Device · Class II · 2014-10-22 · Arjo - 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory
FDA Device · Class II · 2014-10-22 · Baxter Healthcare - Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
FDA Device · Class I · 2014-10-22 · Covidien - Omni Micro-electrode/reference electrode for cobas b221 analyzer
FDA Device · Class III · 2014-10-22 · Roche Diagnostics Operations - EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000
FDA Device · Class II · 2014-10-22 · Intuitive Surgical - ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualit…
FDA Device · Class II · 2014-10-22 · Ameditech - Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and r…
FDA Device · Class II · 2014-10-22 · Biomet - External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer
FDA Device · Class II · 2014-10-22 · Siemens Healthcare Diagnostics - VITROS 5600 Integrated System, System Product Code 6802413
FDA Device · Class II · 2014-10-22 · Ortho Clinical Diagnostics - MediChoice¿ Multifunction Electrode Part Number: MC171 OH
FDA Device · Class I · 2014-10-22 · Covidien - Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
FDA Device · Class I · 2014-10-22 · Covidien - Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
FDA Device · Class I · 2014-10-22 · Covidien - StarMedTec LightTrail¿ Reusable Fibers, 600 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - Richard-Allan Scientific 10% Neutral Buffered Formalin
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - Richard-Allan Scientific Specimen Transportation System
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577
FDA Device · Class II · 2014-10-15 · Sterilmed - Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor res…
FDA Device · Class II · 2014-10-15 · Biomet - RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collec…
FDA Device · Class II · 2014-10-15 · Smith And Nephew - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M022…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- I…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - Richard-Allan Scientific Bio-Tite Specimen Containers
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for…
FDA Device · Class II · 2014-10-15 · Smith And Nephew - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M230…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzym…
FDA Device · Class II · 2014-10-15 · Siemens Healthcare Diagnostics - Black Mamba Suture Passer
FDA Device · Class II · 2014-10-15 · Biomet - Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These M…
FDA Device · Class II · 2014-10-15 · Bio Detek - McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data pro…
FDA Device · Class II · 2014-10-15 · Mckesson Information Solutions - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological exam…
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - Mamba Disposable Nitinol Needle
FDA Device · Class II · 2014-10-15 · Biomet - ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single
FDA Device · Class II · 2014-10-15 · Bio Detek - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M184…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - Green Mamba Suture Passer
FDA Device · Class II · 2014-10-15 · Biomet - MaxLock Extreme Mod-Foot Concave Reamer
FDA Device · Class II · 2014-10-15 · Orthohelix Surgical Designs - Richard-Allan Scientific 10% Neutral Buffered Formalin
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M050…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- I…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12
FDA Device · Class II · 2014-10-15 · Nemschoff Chairs - Biomedix SELEC-3 I.V. Administration Set
FDA Device · Class II · 2014-10-15 · Biomedix - StarMedTec LightTrail¿ Reusable Fibers, 365 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection wit…
FDA Device · Class II · 2014-10-15 · Bio Detek - RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to…
FDA Device · Class II · 2014-10-15 · Depuy Orthopaedics - StarMedTec LightTrail¿ Reusable Fibers, 800 um
FDA Device · Class II · 2014-10-15 · Boston Scientific - Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd
FDA Device · Class II · 2014-10-15 · Depuy Orthopaedics - The Hulka Clip is a sterile packaged medical device that carries a two year expiration date
FDA Device · Class II · 2014-10-15 · Richard Wolf Medical Instruments - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- I…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - GE Healthcare Carescape Patient Data Module
FDA Device · Class II · 2014-10-15 · Ge Healthcare - RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collec…
FDA Device · Class II · 2014-10-15 · Smith And Nephew - PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M140…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes…
FDA Device · Class II · 2014-10-15 · Bio Detek - BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog…
FDA Device · Class II · 2014-10-15 · Navilyst Medical - ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg)
FDA Device · Class II · 2014-10-15 · Arjo Hospital Equipment Ab - Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
FDA Device · Class II · 2014-10-15 · Philips Medical Systems - Cardinal Health Prefilled Buffered 10% Formalin
FDA Device · Class I · 2014-10-15 · Richard Allan Scientific - Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographi…
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach
FDA Device · Class II · 2014-10-08 · Gendex - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System
FDA Device · Class II · 2014-10-08 · Intuitive Surgical - Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic s…
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pat…
FDA Device · Class II · 2014-10-08 · Lumenis
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