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.
- Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat
FDA Device · Class II · 2013-09-04 · Stryker Howmedica Osteonics - 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialy…
FDA Device · Class II · 2013-09-04 · Fresenius Medical Care Holdings - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular…
FDA Device · Class II · 2013-09-04 · Synthes Usa Hq - SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - PrepStain Tecan US-II. For use in the screening and detection of cervical cancer
FDA Device · Class II · 2013-09-04 · Becton Dickinson And - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Synthes Trauma Nail System
FDA Device · Class II · 2013-09-04 · Synthes Usa Hq - Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin)
FDA Device · Class II · 2013-09-04 · Medtronic Cardiac Rhythm Disease Management - GE Healthcare, TRAM MODULE, High-acuity patient monitoring
FDA Device · Class II · 2013-09-04 · Ge Healthcare - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware
FDA Device · Class II · 2013-09-04 · Integra - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - 00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for:…
FDA Device · Class II · 2013-08-28 · Getinge Usa - 00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, D…
FDA Device · Class II · 2013-08-28 · Gyrus Medical - 00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Stryker Visum 300 Ceiling-mounted Exam Light
FDA Device · Class II · 2013-08-28 · Stryker Communications - Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch,…
FDA Device · Class II · 2013-08-28 · Aspen Surgical Products - 00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories
FDA Device · Class II · 2013-08-28 · Endogastric Solutions - CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person
FDA Device · Class II · 2013-08-28 · Invacare - The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging…
FDA Device · Class II · 2013-08-28 · Ge Healthcare - Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length
FDA Device · Class II · 2013-08-28 · Zimmer - 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs
FDA Device · Class II · 2013-08-28 · Sorin Group Usa - 00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Boston Scientific, ENERGEN DR ICD, Model E143
FDA Device · Class II · 2013-08-28 · Boston Scientific Crm - 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini
FDA Device · Class I · 2013-08-28 · Stryker Spine - 00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid s…
FDA Device · Class III · 2013-08-28 · Convatec - 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Philips Healthcare MobileDiagnostwDR system
FDA Device · Class II · 2013-08-28 · Philips Healthcare - 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations
FDA Device · Class II · 2013-08-28 · Ge Healthcare - 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of l…
FDA Device · Class III · 2013-08-28 · Convatec - 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Blue Belt Technologies, Inc
FDA Device · Class II · 2013-08-28 · Blue Belt Technologies Mn - 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - PleuraGuide Disposable Chest Tube Kit
FDA Device · Class II · 2013-08-28 · Atrium Medical - 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - 00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type ins…
FDA Device · Class II · 2013-08-28 · Medtronic Minimed - 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage:…
FDA Device · Class II · 2013-08-28 · Smith And Nephew - Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for det…
FDA Device · Class II · 2013-08-28 · Beckman Coulter - 00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile
FDA Device · Class II · 2013-08-28 · Zimmer - Product Name: nanoPOINT Injector System, item number 37-0000-08
FDA Device · Class II · 2013-08-28 · Medicel Ag - ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915
FDA Device · Class II · 2013-08-21 · Beckman Coulter - C-QUR TacShield Mesh (All sizes and shapes)
FDA Device · Class II · 2013-08-21 · Atrium Medical - Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for us…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrume…
FDA Device · Class II · 2013-08-21 · Zimmer - Arrow International, Inc
FDA Device · Class II · 2013-08-21 · Arrow International - Synthes Flexible Medullary Reamer
FDA Device · Class II · 2013-08-21 · Synthes Usa Hq - Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear…
FDA Device · Class II · 2013-08-21 · Medtronic Xomed - Invue Solid Driver, Tipped, AO. Part Number: 11-70083
FDA Device · Class II · 2013-08-21 · Spinefrontier - 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circ…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is ind…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below
FDA Device · Class II · 2013-08-21 · Veridex - Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
FDA Device · Class II · 2013-08-21 · Biomet 3i - Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for us…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - C-QUR Edge Mesh (All sizes and shapes)
FDA Device · Class II · 2013-08-21 · Atrium Medical - StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and per…
FDA Device · Class II · 2013-08-21 · Medtronic Navigation - REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrume…
FDA Device · Class II · 2013-08-21 · Zimmer
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)