FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems…
FDA Device · Class II · 2013-02-27 · Hill Rom - HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Su…
FDA Device · Class II · 2013-02-27 · Healthtronics - NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of i…
FDA Device · Class III · 2013-02-27 · Animas - NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50
FDA Device · Class II · 2013-02-27 · International Technidyne - NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified…
FDA Device · Class II · 2013-02-27 · Philips Healthcare - STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system
FDA Device · Class II · 2013-02-27 · Stryker Sustainability Solutions - NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - LifeStyles ZERO 10 uber-thin lubricated latex condoms
FDA Device · Class II · 2013-02-27 · Ansell Healthcare Products - NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Monaco RTP System
FDA Device · Class II · 2013-02-27 · Elekta - NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t…
FDA Device · Class I · 2013-02-27 · Depuy Orthopaedics - ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED C…
FDA Device · Class II · 2013-02-27 · Conmed - LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t…
FDA Device · Class I · 2013-02-27 · Depuy Orthopaedics - VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096
FDA Device · Class II · 2013-02-27 · Greiner Bio One North America - Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary sy…
FDA Device · Class II · 2013-02-27 · Merit Medical Systems - NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t…
FDA Device · Class I · 2013-02-27 · Depuy Orthopaedics - NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, C…
FDA Device · Class II · 2013-02-27 · Integra Lifesciences - NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic
FDA Device · Class II · 2013-02-20 · Quidel - Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used…
FDA Device · Class III · 2013-02-20 · Ultradent Products - Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2&quot
FDA Device · Class II · 2013-02-20 · Naimco - Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar
FDA Device · Class II · 2013-02-20 · Mizuho Osi - The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation an…
FDA Device · Class I · 2013-02-20 · Lumenis - GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator…
FDA Device · Class I · 2013-02-20 · Ge Healthcare - Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhyt…
FDA Device · Class II · 2013-02-20 · Viterion Telehealthcare - The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionell…
FDA Device · Class II · 2013-02-20 · Remel - Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5&quot
FDA Device · Class II · 2013-02-20 · Naimco - Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System
FDA Device · Class II · 2013-02-20 · Terumo Cardiovascular Systems - Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems
FDA Device · Class II · 2013-02-20 · Lockheed Martin Gyrocam Systems - BREG Sterile Polar Pads
FDA Device · Class II · 2013-02-20 · Breg - Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Us…
FDA Device · Class II · 2013-02-20 · Philips Healthcare - Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877,…
FDA Device · Class II · 2013-02-20 · Naimco - GE Healthcare, Dash Port 2 Docking Station
FDA Device · Class II · 2013-02-20 · Ge Healthcare - GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories
FDA Device · Class II · 2013-02-20 · Ge Healthcare - Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650
FDA Device · Class II · 2013-02-20 · Remel - Fresenius Liberty Cycler Set Single Conn
FDA Device · Class II · 2013-02-20 · Fresenius Medical Care Holdings - GE Healthcare, CARESCAPE Monitor B650
FDA Device · Class II · 2013-02-20 · Ge Healthcare - St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System
FDA Device · Class I · 2013-02-20 · St Jude Medical - Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box
FDA Device · Class II · 2013-02-20 · Remel - Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640
FDA Device · Class II · 2013-02-20 · Remel - Chenica Gunnell Rehab Series of Wheelchairs (GRSW)
FDA Device · Class II · 2013-02-20 · Chenica - BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012
FDA Device · Class II · 2013-02-20 · Breg - Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detectio…
FDA Device · Class II · 2013-02-20 · Viterion Telehealthcare - Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2&quot
FDA Device · Class II · 2013-02-20 · Naimco - Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack
FDA Device · Class II · 2013-02-20 · Mindray Ds Usa D B A Mindray North America - Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. U…
FDA Device · Class III · 2013-02-20 · Ultradent Products - Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide…
FDA Device · Class II · 2013-02-20 · Aesculap - Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty
FDA Device · Class II · 2013-02-20 · Bacterin International - Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag…
FDA Device · Class I · 2013-02-20 · Ge Healthcare - Viterion TeleHealth Monitor Model Number V500
FDA Device · Class II · 2013-02-20 · Viterion Telehealthcare - Trilogy Acetabular Shells with Holes
FDA Device · Class II · 2013-02-13 · Zimmer - Trilogy F/M Acetabular Shell with Uni-Hole
FDA Device · Class II · 2013-02-13 · Zimmer - PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel fra…
FDA Device · Class II · 2013-02-13 · Winco Mfg - Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012
FDA Device · Class II · 2013-02-13 · Synthes Usa Hq - Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System
FDA Device · Class II · 2013-02-13 · Medacta Usa - Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53
FDA Device · Class II · 2013-02-13 · Exactech - Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard
FDA Device · Class II · 2013-02-13 · The Anspach Effort - OPTIGEN Food 30
FDA Device · Class III · 2013-02-13 · Hitachi Chemical Diagnostics - Trilogy Acetabular Shell Spiked
FDA Device · Class II · 2013-02-13 · Zimmer - Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case
FDA Device · Class II · 2013-02-13 · Custom Healthcare Systems - Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position
FDA Device · Class II · 2013-02-13 · Invacare - KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL N…
FDA Device · Class III · 2013-02-13 · Carestream Health - Trilogy Acetabular AB Shells with Cluster Holes
FDA Device · Class II · 2013-02-13 · Zimmer - Trilogy F/M Acetabular Shell without holes
FDA Device · Class II · 2013-02-13 · Zimmer - Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification…
FDA Device · Class III · 2013-02-13 · Diagnostic Hybrids - PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012
FDA Device · Class II · 2013-02-13 · Winco Mfg - Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400
FDA Device · Class II · 2013-02-13 · Oxus America - Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel &am…
FDA Device · Class II · 2013-02-13 · Remel - ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
FDA Device · Class II · 2013-02-13 · Linvatec - Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjus…
FDA Device · Class II · 2013-02-13 · Synthes Usa Hq - Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012
FDA Device · Class II · 2013-02-13 · Winco Mfg - Trilogy Acetabular Shell with Cluster Holes
FDA Device · Class II · 2013-02-13 · Zimmer - Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case
FDA Device · Class II · 2013-02-13 · Custom Healthcare Systems - Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53
FDA Device · Class II · 2013-02-13 · Exactech - THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box
FDA Device · Class II · 2013-02-13 · Lansinoh Laboratories - Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
FDA Device · Class II · 2013-02-13 · Philips Healthcare - Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 6…
FDA Device · Class II · 2013-02-13 · Zimmer - P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device
FDA Device · Class II · 2013-02-13 · Tobii Assistive Technology - Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525
FDA Device · Class II · 2013-02-13 · Ormco Sybronendo - Trilogy Acetabular AB Shells with Holes
FDA Device · Class II · 2013-02-13 · Zimmer - Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012
FDA Device · Class II · 2013-02-13 · Winco Mfg - SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures
FDA Device · Class II · 2013-02-13 · Allergen Medical - BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes
FDA Device · Class II · 2013-02-06 · Becton Dickinson And - Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred…
FDA Device · Class III · 2013-02-06 · Alere San Diego - AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6
FDA Device · Class II · 2013-02-06 · Ge Healthcare - Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 0700…
FDA Device · Class II · 2013-02-06 · Alfa Wassermann - BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** I…
FDA Device · Class II · 2013-02-06 · Becton Dickinson And
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)